Minimally invasive Surgical Option

da Vinci Robotic Surgery

 

da Vinci® Pelvic Prolapse Surgery

 

da-vinci_pelvic_proplapse_incision_comparison

Pelvic prolapse occurs when a pelvic organ, such as your vagina or uterus slips out of its normal position. Surgery to correct this condition is called sacrocolpopexy. During surgery, doctors use surgical mesh to keep your pelvic organ(s) in the correct spot and ease your symptoms.

Pelvic prolapse surgery can be done with open surgery through one large incision (cut). It can also be done with minimally invasive surgery using traditional laparoscopy or da Vinci Surgery.

Why da Vinci  Surgery?

The da Vinci System is a robotic-assisted surgical device that your surgeon is 100% in control of at all times. The da Vinci System gives surgeons:

  • A 3D HD view inside your body
  • Special wristed instruments that bend and rotate far greater than the human hand
  • Enhanced vision, precision and control

da Vinci Sacrocolpopexy offers the following potential benefits compared to open surgery:

  • Lower rate of complications
  • Less estimated blood loss
  • Similar rate of blood transfusions
  • Shorter hospital stay

da Vinci Sacrocolpopexy offers the following potential benefits compared to traditional laparoscopy:

  • Similar rate of complications
  • Similar rate of blood transfusions
  • Similar or less estimated blood loss
  • Similar or shorter hospital stay
  • Similar conversion rate (switch to open surgery)

A sacrocolpopexy can also be done after a hysterectomy (removal of uterus) to provide long-term support for the vagina.

The da Vinci System has brought minimally invasive surgery to more than 3 million patients worldwide. da Vinci technology – changing the experience of surgery for people around the world.

Learn more about the da Vinci Surgical System.

Risks & Considerations Related to Sacrocolpopexy (pelvic prolapse surgery):mesh erosion/infection caused by mesh moving from vaginal wall into surrounding organs causing the need for another operation, injury to rectum/bowel, injury to bladder (organ that holds urine), injury to the ureters (the ureters drain urine from the kidney into the bladder), front wall of the rectum pushes into the back wall of the vagina, prolapsed bladder (bladder budges into vagina when supportive tissue weakens), vaginal incision opens or separates, loss of bladder control, pooling of blood between bladder and pubic bone, pooling of blood between the anus and vagina.

 

IMPORTANT SAFETY INFORMATION

Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Individual surgical results may vary. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. Please also refer to http://www.daVinciSurgery.com/Safety for Important Safety Information.

©2018 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders. The information on this website is intended for a United States audience only.

Should I Consider da Vinci® Surgery?

Most people are candidates for da Vinci Surgery, but it may not be right for everyone. Only you and your doctor can decide whether Surgery is right for you. Before making your decision, you should make sure you are aware of all the options available to you, as well as your physician’s experience as a da Vinci surgeon.

To determine if you are a candidate for da Vinci Surgery, and to ensure you get the information you need from a consultation with your physician, we have put together a brief questionnaire that you can take into your doctor’s appointment with you.

Download Brochure: Am I a Candidate?


While clinical studies support the effectiveness of the da Vinci® System when used in minimally invasive surgery, individual results may vary. Surgery with the da Vinci Surgical System may not be appropriate for every individual. Always ask your doctor about all treatment options, as well as their risks and benefits.

Content provided by Intuitive Surgical. For more information on this topic, please visit www.davincisurgery.com

 

The da Vinci Surgical System

The da Vinci® Surgical System enables surgeons to perform operations through a few small incisions and features several key features, including:

  • Magnified vision system that gives surgeons a 3D HD view inside the patient’s body
  • Ergonomically designed console where the surgeon sits while operating
  • Patient-side cart where the patient is positioned during surgery
  • Wristed instruments that bend and rotate far greater than the human hand

The da Vinci S Surgical System 
The da Vinci S Surgical Robot

The da Vinci System is powered by robotic technology that allows the surgeon’s hand movements to be translated into smaller, precise movements of tiny instruments inside the patient’s body. One of the instruments is a laparoscope – a thin tube with a tiny camera and light at the end. The camera sends images to a video monitor in the operating room to guide doctors during surgery. The surgeon is 100% in control of the da Vinci System at all times.

The da Vinci System has brought minimally invasive surgery to more than 3 million patients worldwide. da Vinci technology – changing the experience of surgery for people around the world.

IMPORTANT SAFETY INFORMATION

Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Individual surgical results may vary. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. Please also refer to http://www.daVinciSurgery.com/Safety for Important Safety Information.

©2018 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders. The information on this website is intended for a United States audience only.

FAQ

What is Minimally Invasive Surgery (MIS)?

 MIS is surgery typically performed through small incisions, or operating ports, rather than large incisions. This can potentially result in shorter recovery times, fewer complications, reduced hospitalization costs and reduced trauma to the patient. While MIS has become standard-of-care for particular surgical procedures, it has not been widely adopted for more complex or delicate procedures – for example, prostatectomy and mitral valve repair.

Intuitive Surgical believes that surgeons have been slow to adopt MIS for complex procedures because they generally find that fine-tissue manipulation – such as dissecting and suturing – is more difficult than in open surgery. Intuitive Surgical’s technology, however, enables the use of MIS techniques for complex procedures.

Why do we need a new way to do minimally invasive surgery?

Despite the widespread use of minimally invasive or laparoscopic surgery in today’s hospitals, adoption of laparoscopic techniques, for the most part, has been limited to a few routine procedures. This is due mostly to the limited capabilities of traditional laparoscopic technology, including standard video and rigid instruments, which surgeons must rely on to operate through small incisions.

In traditional open surgery, the physician makes a long incision and then widens it to access the anatomy. In traditional minimally invasive surgery – which is widely used for routine procedures – the surgeon operates using rigid, hand-operated instruments, which are passed through small incisions and views the anatomy on a standard video monitor. Neither this laparoscopic instrumentation nor the video monitor can provide the surgeon with the excellent visualization needed to perform complex surgery like mitral valve repair or nerve-sparing prostatectomy.

What are the benefits of da Vinci Surgery compared with traditional methods of surgery?

Some of the major benefits experienced by surgeons using the da Vinci Surgical System over traditional approaches have been greater surgical precision, increased range of motion, improved dexterity, enhanced visualization and improved access. Benefits experienced by patients may include a shorter hospital stay, less pain, less risk of infection, less blood loss, fewer transfusions, less scarring, faster recovery and a quicker return to normal daily activities. None of these benefits can be guaranteed, as surgery is necessarily both patient- and procedure-specific.

Where is the da Vinci Surgical System being used now?

Currently, The da Vinci Surgical System is being used in hundreds of locations worldwide, in major centers in the United States, Austria, Belgium, Canada, Denmark, France, Germany, Italy, India, Japan, the Netherlands, Romania, Saudi Arabia, Singapore, Sweden, Switzerland, United Kingdom, Australia and Turkey.

Has the da Vinci Surgical System been cleared by the FDA?

The U.S. Food and Drug Administration (FDA) has cleared the da Vinci Surgical System for a wide range of procedures. Please see the FDA Clearance page for specific clearances and representative uses.

Is da Vinci Surgery covered by insurance?

da Vinci Surgery is categorized as robot-assisted minimally invasive surgery, so any insurance that covers minimally invasive surgery generally covers da Vinci Surgery. This is true for widely held insurance plans like Medicare. It is important to note that your coverage will depend on your plan and benefits package. For specifics regarding reimbursement for da Vinci Surgery, or if you have been denied coverage, please call the Reimbursement Hotline at 1-888-868-4647 ext. 3128. From outside the United States, please call 33-1-39-04-26-90.

Will the da Vinci Surgical System make the surgeon unnecessary?

On the contrary, the da Vinci System enables surgeons to be more precise, advancing their technique and enhancing their capability in performing complex minimally invasive surgery. The system replicates the surgeon’s movements in real time. It cannot be programmed, nor can it make decisions on its own to move in any way or perform any type of surgical maneuver without the surgeon’s input.

Is a surgeon using the da Vinci Surgical System operating in "virtual reality"?

Although seated at a console a few feet away from the patient, the surgeon views an actual image of the surgical field while operating in real-time, through tiny incisions, using miniaturized, wristed instruments. At no time does the surgeon see a virtual image or program/command the system to perform any maneuver on its own/outside of the surgeon’s direct, real-time control.

Is this telesurgery? Can you operate over long distances?

The da Vinci Surgical System can theoretically be used to operate over long distances. This capability, however, is not the primary focus of the company and thus is not available with the current da Vinci Surgical System.

While using the da Vinci Surgical System, can the surgeon feel anything inside the patient's chest or abdomen?

The system relays some force feedback sensations from the operative field back to the surgeon throughout the procedure. This force feedback provides a substitute for tactile sensation and is augmented by the enhanced vision provided by the high-resolution 3D view.

What procedures have been performed using the da Vinci Surgical System? What additional procedures are possible?

The da Vinci System is a robotic surgical platform designed to enable complex procedures of all types to be performed through 1-2 cm incisions or operating “ports.” To date, tens of thousands of procedures including general, urologic, gynecologic, thoracoscopic, and thoracoscopically-assisted cardiotomy procedures have been performed using the da Vinci Surgical System.

Why is it called the da Vinci Surgical System?

The product is called “da Vinci” in part because Leonardo da Vinciinvented the first robot. He also used unparalleled anatomical accuracy and three-dimensional details to bring his masterpieces to life. The da Vinci Surgical System similarly provides physicians with such enhanced detail and precision that the System can simulate an open surgical environment while allowing operation through tiny incisions.

While clinical studies support the effectiveness of the da Vinci® System when used in minimally invasive surgery, individual results may vary. Surgery with the da Vinci Surgical System may not be appropriate for every individual. Always ask your doctor about all treatment options, as well as their risks and benefits.

Content provided by Intuitive Surgical. For more information on this topic, please visit www.davincisurgery.com

  • Serati M, et al; 2014. Robot-assisted Sacrocolpopexy for Pelvic Organ Prolapse: A Systematic Review and Meta-Analysis of Comparative Studies. European Urology. 66:202-318.
  • Nosti Patrick A., Uduak Umoh Andy, Sarah Kane, Dena E. White, Heidi S. Harvie, Lior Lowenstein, and Robert E. Gutman.. “Outcomes of Abdominal and Minimally Invasive Sacrocolpopexy.” Female Pelvic Medicine & Reconstructive Surgery 20.1 (2014): 33-37.
  • Siddiqui Nazema Y., Elizabeth J. Geller, and Anthony G. Visco. Symptomatic and Anatomic 1-year Outcomes after Robotic and Abdominal Sacrocolpopexy. American Journal of Obstetrics and Gynecology 206.5 (2012): 435.e1-35.e5.
  • Anger JT, et al; 2014. Robotic Compared with Laparoscopic Sacrocolpopexy. A Randomized Controlled Trial. Obstetrics & Gynecology. 123(1)5-12.
  • Flack CK, et al; 2015. National Trends in the Performance of Robot-Assisted Sacrocolpopexy. J Endourology Jul;29(7):777-83. doi: 10.1089/end.2014.0710. Epub 2015 Mar 10.
  • Paraiso MF, et al; 2011. Laparoscopic Compared with Robotic Sacrocolpopexy for Vaginal Prolapse. A Randomized Controlled Trial. Obstetrics & Gynecology. 118(5)1005-1013.
  • National Institutes of Health. Uterine Prolapse. Available from: www.nlm.nih.gov/medlineplus/ency/article/001508.htm

IMPORTANT SAFETY INFORMATION

Important Safety Information

Surgical Risk Document

Patient Facing

Serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Also, some medical conditions can increase the risks of any surgery. Patients should discuss pertinent surgical risks with their doctors.

This document provides a summary of the risks associated with surgery and includes four different sections.

  • Section I includes the negative outcomes, risks and complications of any type of surgery.
  • Section II includes the negative outcomes, risks and complications of minimally invasive surgical techniques.
  • Section III includes the negative outcomes, risks and complications of da Vinci surgery.
  • Section IV includes the negative outcomes, risks and complications of representative, specific surgical procedures.

 

I. Negative Outcomes, Risks, and Complications of Any Surgical Type

This section covers negative outcomes, risks and complications associated with any type of surgery. Common approaches/methods of surgery include: open surgery (through a large incision), thoracotomy incision (through a large chest incision), transoral surgery (through the mouth), thoracoscopic or laparoscopic surgery (through a few small incisions or the belly button) with traditional laparoscopy or da Vinci robotic-assisted laparoscopy.

1. During Surgery

    • Loss of a large amount of blood (blood transfusion needed)
    • Any inadvertent cut, tear, puncture, burn or injury to organ , structure, or tissue , including , but not limited to:
  • Major blood vessel
  • Hollow organ, such as the bowel or bladder
  • Solid organ, such as the spleen, kidney, heart , lungs or liver
  • Ureter (tubes that carry urine from the kidneys to the bladder)
  • Nerves
  • Loss of a needle, piece of an instrument, particulate or any other object used during surgery in patient’s body
  • Anesthesia risks (anesthesia is medicine that allows patients to sleep deeply and not feel pain during surgery): heart attack, stroke, blood clotting deep in the body, blocked lung artery, pneumonia (serious lung infection), dental injury, injury to the vocal cord and death
  • Patient positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries

2. After Surgery

The complications listed below may go away on their own, with standard treatment from a doctor, or may require: medicine, radiological intervention (allows doctors to see inside your body with imaging such as X-rays, CT or MRI scans or ultrasound), admission back into the hospital, extended hospital stay, and/or another operation.

  • Bleeding
  • Urinary tract infection and/or urine will not empty completely from the bladder
  • Blocked intestine or small bowel, nausea/vomiting
  • Heart attack or irregular heartbeat, inflammation of the sac covering the heart
  • Blood clot in a vessel that breaks away and travels to another blood vessel (often in the brain, GI tract, kidneys or leg), blood clotting deep inside the body, or blocked lung artery (usually blocked by a blood clot)
  • Collapsed lung, pneumonia (serious lung infection), build-up of fluid between the layers of tissue lining the lungs and chest cavity, abnormal build-up of fluid in the air sacs of the lungs which leads to shortness of breath, need for re-intubation (tube inserted in the mouth to help support breathing), or prolonged intubation
  • Infection, blood build-up outside of vessels, fluid build-up, pus build-up in the abdomen, pelvis or chest
  • Infection of the cavity where organs like the stomach and colon lie
  • Breakdown and release of muscle fiber into the blood stream which can cause kidney damage
  • Injury to adjacent organs
  • Large amount of drainage from wound, or drainage which lasts a long period of time
  • Infection at the incision site
  • Bursting of the wound at the incision site
  • Hernia (bulging of organ or fatty tissue) at the incision site
  • Sudden kidney failure
  • Nerve disorder that causes weakness, numbness, tingling or pain (neuropathy)
  • Loss of vision that lasts for a short period of time or does not go away
  • Spread of cancer cells
  • Major stroke or mini “warning” stroke
  • Inability to work
  • Symptoms or disease may return
  • Death

 

II. Negative Outcomes, Risks and Complications of Minimally Invasive Surgery

This section covers negative outcomes, risks and complications of minimally invasive surgery (through one or a few small incisions), in addition to the risks above. Examples include traditional laparoscopy, thoracoscopy, transoral endoscopy and da Vinci robotic-assisted laparoscopy.

1. During Surgery

  • Surgeon must switch from minimally invasive surgery to open surgery (through a large incision) or hand-assisted surgery. This is usually due to: patient anatomy/frame, severe scarring or swelling of tissues, injury during surgery, technical challenges, cancer or disease that can be seen in more places than first thought, or the patient cannot tolerate gas/air in abdomen (used to inflate the abdomen during minimally invasive surgery)
  • Longer operating and anesthesia time
  • Surgical instrument or equipment injures hollow or solid organ(s) or blood vessel(s)
  • Short-term nerve damage caused by how the patient was positioned on the operating table
  • Complications or injury to the eyes/vision, face or larynx (voice box) caused when the patient’s head is placed lower than his/her feet on the operating table
  • Temporary swelling of tissue due to gas in the tissue
  • Changes in heart rate, blood pressure or blood values due to absorption of the gas used during minimally invasive surgery

2. After Surgery

  • Shoulder pain
  • Pain from the gas used during the surgery

III. Negative Outcomes, Risks, and Complications of da Vinci Robotic–Assisted Surgery

In addition to the risks in I and II above, which are not unique to da Vinci, this section covers negative outcomes, risks and complications of da Vinci robotic-assisted surgery. Surgery using the da Vinci robotic surgical system may be associated with longer operative and anesthesia times. As with any surgical device, there is also the risk that the da Vinci robotic surgical system could malfunction or fail leading to serious injury or the need to switch to another type ofsurgical approach. Switching to another surgical approach could also result in a longer procedure time, a longer time under anesthesia and increased complications.

IV. Negative Outcomes, Risks, and Complications of Representative, Specific Procedures

This section covers negative outcomes, risks, and complications of representative, specific procedures in addition to the risks listed in sections I, II and III. It is not based on whether the surgeon operates using open surgery, a large chest incision, traditional laparoscopy or da Vinci robotic-assisted laparoscopy.
Note :Not all procedures listed below are available for all da Vinci systems, instruments and accessories

UROLOGY

Radical Prostatectomy (removal of prostate gland and some surrounding tissue): leaking of urine, urgent need to urinate, cannot get or keep an erection, rectal or bowel injury, narrowing of the urethra, pooling of lymph fluid in the pelvic area or legs.

 

Pyeloplasty (surgery for a urinary blockage): infection of the kidney, leaking of urine, narrowing of the urethra, bowel injury, kidney stones, narrowing or movement of the stent, blood in the urine, prolonged leaking of urine.

 

Cystectomy (removal of all/part of the bladder): leaking of urine, injury to the rectum, scar tissue that causes narrowing between two connected structures, fistula (abnormal bond of an organ, intestine or vessel to another part of the body), leaking of urine, urgent need to urinate, cannot get or keep an erection, abnormal pooling of lymph fluid.

Nephrectomy (kidney removal):  poor kidney function often due to limited blood flow, leaking of urine, cut or tear in the spleen, pancreas or liver, bowel injury, trapped air between the chest wall and lung, injury to diaphragm (muscle separating the chest from the abdomen), urinary fistula (abnormal bond of an organ, intestine or vessel to another part of the body), abnormal pooling of urine, limited or cut off blood supply to kidney, abnormal pooling of lymph fluid.

Ureteral Reimplantation (repositions how ureter connects to bladder): urinary tract infection that affects one or both kidneys, damage to urethra which can cause urine to collect in other areas of the body, scar tissue that causes narrowing at the site of the repair abnormal flow of urine from the bladder backwards to the kidneys.

GYNECOLOGY

Hysterectomy, Benign (removal of the uterus and possibly nearby organs): injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problems (scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates), injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), abnormal hole from the vagina into the urinary tract or rectum, vaginal tear or deep cut.   Uterine tissue may contain unsuspected cancer.  The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Hysterectomy, Cancer (removal of the uterus and possibly nearby organs): injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problem (scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates), injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), abnormal hole from the vagina into the urinary tract or rectum, vaginal tear or deep cut.

Myomectomy (removal of fibroid tumors): tear or hole in uterus, split or bursting of the uterus, pre-term (early) birth, spontaneous abortion.  Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine or fibroid  tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Sacrocolpopexy (pelvic prolapse surgery): mesh erosion/infection caused by mesh moving from vaginal wall into surrounding organs causing the need for another operation, injury to rectum/bowel, injury to bladder (organ that holds urine), injury to the ureters (the ureters drain urine from the kidney into the bladder), front wall of the rectum pushes into the back wall of the vagina, prolapsed bladder (bladder budges into vagina when supportive tissue weakens), vaginal incision opens or separates, loss of bladder control, pooling of blood between bladder and pubic bone, pooling of blood between the anus and vagina.

Endometriosis resection (endometriosis surgery to remove implants): injury to the bowel, bladder (organ that holds urine) or ureters (the ureters drain urine from the kidney into the bladder).

GENERAL SURGERY

Cholecystectomy (gallbladder removal): injury to the common bile duct (tube that carries bile from the gallbladder to the small intestine), leaking bile, inflamed pancreas (pancreatitis), retained stones in the common bile duct.

Nissen Fundoplication (acid reflux surgery): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

Heller Myotomy (swallowing disorder surgery): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, heartburn, reflux, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

Paraesophageal Hernia (stomach bulges into chest through a hole in the diaphragm): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, heartburn, reflux, poor emptying of the stomach, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

Bariatric Surgery includes: gastric bypass (stomach reduction surgery), sleeve gastrectomy and duodenal switch:leaking and/or narrowing at the spot where two parts of the bowel were reconnected, leaking from where the bowel is cut, malnutrition, dumping syndrome (food moves too quickly into small intestine), dehydration, need for supplementation of vitamins, minerals and protein.

Gastrectomy (removal of all/part of the stomach): leaking from the stomach or where the stomach is reconnected to the bowel, narrowing at the spot where stomach is reconnected to the bowel, difficulty swallowing, collapsed lung.

Donor Nephrectomy (kidney removal in donor): poor kidney function, deep cut in the spleen, pancreas or liver, inflamed pancreas, collapsed lung, trapped air between the chest wall and lung, injury to the diaphragm( muscle separating chest from the abdomen), adrenal gland bleeding.

Adrenalectomy (removal of one or both adrenal glands): injury to the spleen, inflamed pancreas, injury to the diaphragm (muscle separating chest from the abdomen), adrenal gland bleeding.

Splenectomy (removal of all/part of the spleen): injury to the pancreas, injury to the kidneys or adrenal glands, inflamed pancreas, leak of pancreatic juices, and blood clot in the portal vein (large vein that moves blood from the spleen and GI tract to the liver).

Hernia Repair (ventral, incisional, umbilical, inguinal): recurrence, bowel injury, infection of mesh, urinary retention. For inguinal hernia repair: testicular injury

Pancreatic Surgery ( removal of all/part of the pancreas): inflamed pancreas, leak of pancreatic or bile juices, narrowing or leaking at the spot where the pancreas is connected to the bowel, injury to the spleen or bowel, insufficient pancreatic function (for example, diabetes), diarrhea, poor stomach emptying.

Bowel Resection and Other Colorectal Procedures (removal of all/part of the intestine): leaking and/or narrowing at the spot where two sections of bowel were reconnected, colorectal or anal dysfunction (cannot empty bowel, frequent bowel movements, leakage or constipation).

CARDIAC SURGERY

Internal Mammary (Thoracic) Artery Mobilization: graft injury,  graft narrowing, cardiac arrest (heart stops beating), a clot of fat, blood or air creates a block in the bloodstream, heart is not able to pump as much blood through the body, bleeding disorder in which blood cannot properly clot, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, irregular heartbeat, heart blockage, lengthy time on a breathing machine (ventilator) of 48 hours or more, blood flow to the breastbone and surrounding structures stops.

Cardiac Tissue Ablation (abnormal heart rhythm procedure): blood vessel becomes blocked by a clot that moved from another part of the body, injury to a blood vessel to the heart, tear in the heart, injury to the esophagus.

Mitral Valve Repair (surgery on an abnormal/leaking mitral valve): repair fails requiring another operation, stroke caused by a clot that gets stuck in smaller arteries of the brain,  heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream, valve infection, irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack,  headache,  memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder cut in the major artery(ies) that sends blood to the pelvis and legs, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac, injury to circumflex coronary artery (blood vessel to heart), inadequate closure.

Endoscopic Atrial Septal Defect Closure (surgery to close a hole between two chambers of the heart): failed closure of the defect, stroke caused by a clot that gets stuck in smaller arteries of the brain,  heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems , fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream,  irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack,  memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder, cut in the major artery(ies) that sends blood to the pelvis and legs, lung dysfunction, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

Mammary to Left Anterior Descending Coronary Artery Anastomosis for Cardiac Revascularization with Adjunctive Mediastinotomy: graft injury or narrowing, blood vessel connection fails requiring another operation, stroke caused by a clot that gets stuck in smaller arteries of the brain, heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream, valve infection, irregular heartbeat that requires a pacemaker, kidney or lung failure, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack, memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder cut in the major artery(ies) that sends blood to the pelvis and legs, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

PEDIATRIC SURGERY

The Intuitive SurgicalEndoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others. The complications and risks listed below are not specific to the pediatric population but apply to procedures under consideration.

Pyeloplasty (surgery for a urinary blockage): infection of the kidney, a leaking of urine, narrowing of the urethra, bowel injury, kidney stones, narrowing or movement of the stent, blood in the urine, prolonged leaking of urine.

Ureteral reimplantation (repositions how ureter connects to bladder): urinary tract infection that affects one or both kidneys, damage to urethra which can cause urine to collect in other areas of the body, scar tissue that causes narrowing at the site of the repair abnormal flow of urine from the bladder backwards to the kidneys.

Cholecystectomy (gallbladder removal): injury to the common bile duct (tube that carries bile from the gallbladder to the small intestine), leaking bile, inflamed pancreas (pancreatitis), retained common bile duct stones.

Nissen Fundoplication (acid reflux surgery):  tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

Aortic Ring Ligation (surgery to repair abnormal aorta/tissue): respiratory system fails (difficult or unable to breathe).

Patent ductus arteriosus (PDA) ligation (surgery to close/repair an opening in the ductus arteriosus blood vessel): abnormal breathing and heart rate, lung arteries stretch/widen, vocal cords do not work normally, lymph fluid collects around the lungs, collapsed lung.

Endoscopic atrial septal defect closure (surgery to close a hole between two chambers of the heart): failed closure of the defect, stroke caused by a clot that gets stuck in smaller arteries of the brain,  heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream,  irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack,  memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder, cut in the major artery(ies) that sends blood to the pelvis and legs, lung dysfunction, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

THORACIC SURGERY

Pulmonary Resection (removal of part of lung): air leaks from lungs, lung infection,  lengthy time on a breathing machine of 48 hours or more,  abnormal/irregular heartbeat, breathing tube needs to be re-inserted, abnormal path between lung airways and lining, lung failure  lymph fluid collects around lungs, difficulty breathing, part of lung that remains becomes twisted, collapsed lung, abnormal vocal cord function.

Esophagectomy (removal of part of esophagus): leaking from the stomach and its connection to the esophageal remnant, lung infection, difficulty breathing heart attack, heart failure, abnormal/irregular heartbeat, abnormal vocal cord function with change in voice or speech, excess lymphatic fluid in the pleural cavity ( space around the lungs)

Mediastinal Mass Resection (chest tumor removal) including  thymectomy (removal of thymus gland): lengthy time on a breathing machine of 48 hours or more, air leaks out of lungs, difficulty breathing, fluid build-up around the heart, mixed respiratory syndrome, collapsed lung, injury to heart, abnormal vocal cord function, lymph fluid collects around lungs, need to cut breastbone.

HEAD AND NECK SURGERY

Thyroidectomy (thyroid gland removal): low levels of parathyroid hormone and calcium, Larynx (voice box) nerve damage that lasts or returns, breathing tube needs to be re-inserted, deep cut in windpipe, abnormal vocal cord function, difficulty breathing, deformed appearance, lasting pain or numbness, cut across arteries and tissue in neck, change in voice or speech.  NOTE: thyroidectomy is not cleared by the FDA in the USA.

Transoral Robotic Surgery-TORS (head & neck surgery): bleeding that may be life-threatening, difficulty swallowing which could include the need for a permanent feeding tube without eating by mouth, breathing tube needs to be re-inserted, need to create breathing hole in the neck (tracheotomy and tracheostomy), need to use breathing tube and ventilator for a long time, changes to or loss of taste, tongue cannot move, difficulty opening mouth, broken teeth, narrowing of throat, changes in speech or voice quality, abnormal path from the gland that produces saliva, vocal cord damage, difficulty speaking, injury to teeth, difficulty breathing due to an airway blockage, loss of feeling in tongue, lip injury, injury to nerves in tongue and weak tongue. NOTE: Transoral Robotic Surgery is intended for use only in benign and early to moderate stage cancerous tumors (classified as T1 or T2) and for benign base of tongue resection procedures.

 

Surgical Risk Document

Surgeon Facing

Serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Certain pre-existing medical conditions can also increase the risks of any surgery. Surgeons should discuss pertinent surgical risks with their patients.

This document provides a summary of the risks associated with surgery and includes four different sections.

  • Section I includes the negative outcomes, risks and complications of any type of surgery.
  • Section II includes the negative outcomes, risks and complications of minimally invasive surgical techniques.
  • Section III includes the negative outcomes, risks and complications of da Vinci Surgery.
  • Section IV includes the negative outcomes, risks and complications of representative, specific surgical procedures.

 

I. Adverse Events, Risks, and Complications of Any Surgical Type

This section covers adverse events, risks, and complications associated with all operative procedures in general and are NOT specific to the surgical method or approach used (for example, abdominal/laparotomy incision (“open surgery”), thoracotomy incision, thoracoscopy, da Vinci system robotic-assisted laparoscopy, and conventional laparoscopy).

1.    Intraoperative

  • Bleeding, excessive >500 mL, requiring blood transfusion
  • Injury (inadvertently caused by laceration, tear, perforation, puncture, electrocautery) to organ , structure,  or tissue , including , but not limited to: major blood vessel, hollow viscous organs (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung), ureter, nerve
  • Loss of needle, instrument fragment or any foreign body during surgery in patient’s body
  • Anesthesia risks (including heart attack, stroke, deep venous thrombosis, pulmonary embolism, pneumonia, dental injury, vocal cord injury and death)
  • Patient positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries

2.    Postoperative
These complications may resolve on their own with non-operative therapy, may require medical/pharmaceutical treatment such as antibiotics, may require radiological intervention such as drain placement or embolization, may require prolonged hospitalization, may require re-admission to the hospital, or may require surgical intervention such as re-operation.

  • Bleeding
  • Urinary: urinary tract infection, urinary retention
  • Gastrointestinal: ileus, nausea/vomiting, small bowel obstruction
  • Cardiac: myocardial infarction, arrhythmia, pericarditis
  • Thromboembolic: deep venous thrombosis, pulmonary embolus
  • Pulmonary: atelectasis, pneumonia, pleural effusion, pulmonary edema, need for re-intubation or prolonged intubation
  • Infection / Hematoma / Fluid Collection / Abscess (intra-abdominal, intra-pelvic, intra- thoracic)
  • Peritonitis
  • Rhabdomyolysis
  • Injury to adjacent organs
  • Serous drainage from wound, prolonged or excessive
  • Wound infection: incisional
  • Fascial dehiscence: incisional
  • Hernia: incisional
  • Renal: acute renal failure
  • Neuropathy; persistent pain
  • Visual loss, temporary or permanent
  • Spread of cancer cells
  • Cerebrovascular: transient ischemic attack, ischemic or hemorrhagic stroke
  • Inability to work
  • Recurrence of disease or symptoms
  • Death

 

II. Adverse Events, Risks, and Complications of Minimally Invasive Surgery

This section covers adverse events, risks and complications associated specifically with operative procedures performed minimally invasively through an endoscopic approach in addition to the above listed risks(for example, conventional laparoscopy, transoral endoscopy and da Vinci system robotic-assisted laparoscopy).

1.    Intraoperative

 

  • Conversion to open or hand-assisted surgery (typically due to patient anatomy, severe inflammation or adhesions, intraoperative injury, technical malfunction, extent of malignant invasion, extent of disease, or inability of patient to tolerate pneumoperitoneum)
  • Veress needle or trocar injury to hollow viscous (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung) or blood vessel
  • Longer operative and anesthesia time
  • Neuropraxia related to patient positioning
  • Ocular or laryngeal-facial complications related to trendelenberg position
  • Subcutaneous emphysema
  • Hemodynamic and physiologic changes from the pneumoperitoneum and gas used

2.    Postoperative

    • Shoulder pain
    • Gas pain

 

III. Adverse Events, Risks and Complications of da Vinci robotic –assisted surgery

In addition to the risks in I and II above, which are not unique to da Vinci, this section covers negative outcomes, risks and complications of da Vinci robotic-assisted surgery. Surgery facilitated by the da Vinci Surgical System may be associated with longer operative and anesthesia times than surgery with other approaches. As with any surgical device, there is also the risk that the da Vinci robotic surgical system could malfunction or fail leading to serious injury or the need to switch to another type ofsurgical approach. Switching to another surgical approach could also result in a longer procedure time, a longer time under anesthesia and increased complications.

IV. Adverse Events, Risks and Complications of Representative Specific Procedures

This section covers adverse events, risks and complications associated with specific operative procedures, not specific to the surgical method or approach used (for example, abdominal/laparotomy incision, thoracotomy incision, da Vinci system robotic-assisted laparoscopy, and conventional laparoscopy). These procedural risks are in addition to the risks described under Sections I, II and III above.
Note :Not all procedures listed below are available for all da Vinci systems, instruments and accessories

UROLOGY

Radical Prostatectomy: surrounding nerve damage which can lead to urinary incontinence and/or erectile dysfunction, rectal or bowel injury, urethral stricture, lymphocele, lymphedema; bowel obstruction

Pyeloplasty: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

Cystectomy: urine leak, rectal injury, anastomotic stricture, fistula formation, incontinence, impotence, pelvic lymphocele

Nephrectomy:  renal insufficiency, urine leak, splenic, hepatic or pancreatic laceration, bowel injury, pneumothorax, diaphragmatic injury, urinary fistula, urinoma, renal infarction, lymphocele

Ureteral Reimplantation: pyelonephritis, urinary extravasation, anastomotic stricture, ureteral reflux

GYNECOLOGY

Hysterectomy (Benign): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal. Uterine tissue may contain unsuspected cancer.  The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients
Hysterectomy (Malignant): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal.

Myomectomy: uterine perforation, uterine rupture, preterm birth, spontaneous abortion Uterine tissue may contain unsuspected cancer.  The cutting or morcellation of uterine or fibroid  tissue during surgery may spread cancer, and decrease the long-term survival of patients 
Sacrocolpopexy: mesh erosion/infection (if mesh used in repair) with need for re-operation, rectal injury, bladder injury, rectocele, cystocele, urinary tract injury, vaginal cuff dehiscence, urinary incontinence, hematoma (retropubic, perineal or other). 
Endometriosis resection: bowel injury, bladder injury, urinary tract injury

GENERAL SURGERY

Cholecystectomy: common bile duct injury; bile leak; pancreatitis, retained common bile duct stones

Nissen Fundoplication: gastric, duodenal or esophageal perforation, herniation of wrap, slipped wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia, gas bloat syndrome, splenic injury

Paraesophageal and Other Hiatal Hernia Repairs: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia, gas bloat syndrome, delayed gastric emptying, heartbun, reflux

Heller Myotomy: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia, heartburn, reflux

Bariatric Procedures (Sleeve Gastrectomy/ Roux-en-y gastric bypass, Duodenal Switch): anastomotic/staple line leak, malnutrition, anastomotic stricture, dumping syndrome, dehydration, dysphagia

Donor Nephrectomy: renal insufficiency, splenic, pancreatic or hepatic laceration, adrenal hematoma, pancreatitis, pneumothorax, diaphragmatic injury

Gastrectomy: anastomotic or duodenal leak, anastomotic stricture, dysphagia, pneumothorax

Pancreatic Procedures (Pancreatectomy and Whipple Procedure): pancreatitis, pancreatic leak, biliary leak, anastomotic leak, anastomotic stricture, splenic injury, pancreatic insufficiency, intestinal injury, delayed gastric emptying, diarrhea

Adrenalectomy: splenic injury, pancreatitis, diaphragmatic injury, adrenal hematoma

Splenectomy: pancreatic injury, kidney injury, adrenal injury, pancreatitis, pancreatic leak, portal vein thrombosis

Hernia Repair (ventral, incisional, umbilical, inguinal): recurrence, bowel injury, mesh infection, urinary retention. .For inguinal hernia repair: testicular injury
Bowel Resection and Other Colorectal Procedures (Colectomy, Sigmoidectomy, Low Anterior Resection, APR, Intersphincteric Resection, Proctectomy, Rectopexy): anastomotic leak, anastomotic stricture, colorectal or anorectal dysfunction

CARDIAC SURGERY

Internal Mammary Artery Mobilization: graft injury, graft stenosis, cardiac arrest,  embolism, low cardiac output syndrome, persistent coagulopathy, post-pericardiotomy syndrome, structural damage,  arrhythmia, heart block, prolonged ventilation >48 hours, sternal de-vascularization

Cardiac Tissue Ablation: thromboembolism, circumflex artery injury, cardiac perforation, esophageal injury

Mitral Valve Repair: failed repair requiring replacement or repair, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems,  pulmonary edema, acute limb ischemia, valve infection, arrhythmia requiring pacemaker implantation, post-pericardiotomy syndrome (low grade fever and chest pain up to 6 months), pericarditis, persistent coagulopathy, heart attack, pericardial tamponade, memory loss and/or loss of mental clarity, arterial dissection, circumflex coronary artery injury, inadequate closure

Endoscopic Atrial Septal Defect Closure: failed closure of defect, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged  time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems,   pulmonary edema, acute limb ischemia, arrhythmia, heart block, cardiac arrest, hemothorax, pericardial tamponade, valve dysfunction, thromboembolism, thrombus formation, aortic dissection, arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy    

Mammary to Left Anterior Descending Coronary Artery Anastomosis for Cardiac Revascularization with Adjunctive Mediastinotomy: graft injury, graft stenosis, failed anastomosis, cardiac arrest, embolic stroke, aortic dissection, acute limb ischemia, heart attack, arrhythmias, prolonged ventilation >48 hours, prolonged  time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, valve dysfunction, hemothorax, pericardial tamponade, persistent coagulopathy, post-pericardiotomy syndrome, memory loss and/or loss of mental clarity, kidney or lung failure, heart failure

PEDIATRIC SURGERY

The Intuitive Surgical Endoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others. The complications / risks listed below are not specific to the pediatric population but are applicable for procedures under consideration. 
Pyeloplasty: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

Ureteral Reimplantation: pyelonephritis, urinary extravasation, anastomotic stricture, voiding dysfunction,

Cholecystectomy: common bile duct injury; bile leak; pancreatitis, retained common bile duct stones

Nissen Fundoplication gastric, duodenal or esophageal perforation, herniation of wrap, slipped wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia, gas bloat syndrome, splenic injury 
Aortic Ring Ligation: respiratory failure

Patent Ductus Arteriosus Ligation: cardiorespiratory instability, ductal pseudoaneurysm, vocal cord dysfunction, pneumothorax, chylothorax, pulmonary arterial dilatation

Atrial Septal Defect Closure: structural deterioration of repair, arrhythmia, heart block, cardiac arrest, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, hemothorax, pericardial tamponade, valve dysfunction,  thromboembolism, thrombus formation, aortic dissection, acute limb ischemia arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy

THORACIC SURGERY

Pulmonary Resection (Wedge Resection, Segmentectomy, Lobectomy): persistent air leak, pneumonia, prolonged mechanical ventilation >48 hours, atrial fibrillation, acute respiratory distress syndrome (ARDS), chylothorax, re-intubation, arrhythmias, bronchopleural fistula, phrenic nerve injury, esophageal injury, difficulty breathing, collapsed lung, pulmonary volvulus, recurrent laryngeal nerve injury leading to vocal cord dysfunction

Esophagectomy: anastomotic leak, pneumonia, cardiac complications (infarction, failure, atrial fibrillation), recurrent laryngeal nerve injury, chyle leak

Mediastinal Mass Resection (including  thymectomy): prolonged ventilation >48 hours, persistent air leak, pericardial effusion, mixed respiratory syndrome, chylothorax, pneumothorax, re-intubation, pneumonia, difficulty breathing, acute respiratory distress syndrome (ARDS), atrial fibrillation, cardiac injury, conversion to sternotomy, recurrent laryngeal nerve injury leading to vocal cord dysfunction, phrenic nerve injury

HEAD AND NECK SURGERY

Thyroidectomy: transient or permanent hypoparathyroidism/hypocalcemia, recurrent laryngeal nerve injury, re-intubation, tracheal laceration, vocal cord dysfunction, cosmetic deformity, persistent pain or numbness, transection of carotid sheath structures.  NOTE: Thyroidectomy is considered an off-label procedure in the US.

Transoral Robotic Surgery (TORS): transoral bleeding which could include life threatening bleeds, difficulty swallowing which could include need for a permanent feeding tube with no eating by mouth, airway obstruction, re-intubation, need for tracheotomy, tracheostomy placement, prolonged intubation and need for ventilation, paralysis of tongue, difficulty opening mouth or trismus, broken teeth, pharyngeal stenosis, laryngeal stenosis, changes in speech or voice quality, salivary gland fistula, vocal cord damage, speech and swallowing dysfunction, dysphagia, dysphonia,  lingual hypoesthesia, lip injury: abrasion, laceration, thermal trauma, dysguesia, hypoglossal nerve injury and tongue-weakness changes in taste sensitivity with loss of sense of taste. NOTE: Transoral Robotic otolaryngology surgical procedures are restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures.

 

PN 1009326 Rev G 12/2016

Important Safety Information

Surgical Risks

Surgeons should counsel their patients that serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. Examples of serious and life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to one or more of the following:

  • Injury to tissues and/or organs
  • Bleeding
  • Infection
  • Internal scarring that can cause long-lasting dysfunction or pain.

Surgeons should discuss these and all risks associated with surgery with their patients, including but not limited to the following:

  • Potential for human error
  • Potential for equipment failure
  • Potential for anesthesia complications

Individual surgical results may vary.

Risk specific to minimally invasive surgery, including da Vinci® Surgery, include but are not limited to:

  • Temporary pain or nerve injury associated with positioning
  • A longer operative time
  • The need to convert the procedure to an open approach.

Converting the procedure could mean a longer operative time, a longer time under anesthesia, and/or the need for additional or larger incisions and/or increased complications.

Surgeons should counsel their patients that there are other surgical approaches available. You should discuss your surgical experience and review these and all risks with your patients. Patients and physicians should review all available information on non-surgical and surgical options in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.

Be sure to read and understand all information in the applicable user manuals, including full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device. Training provided by Intuitive Surgical is limited to the use of its products and does not replace the necessary medical training and experience required to perform surgery.Procedure descriptions are developed with, reviewed and approved by independent surgeons. Other surgical techniques may be documented in publications available at the National Library of Medicine. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, products featured are available for commercial distribution in the U.S. For availability outside the U.S., please check with your local representative or distributor.

Appropriate Use of the da Vinci System
There are several models of the da Vinci System. Below are the cleared indications for use in the U.S. for the various models. Important Safety Information, Instructions for Use, Contraindications, Warnings, and Precautions are included in the product instructions provided with the system, instruments and accessories. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments.

Note: Include only the applicable da Vinci System description(s) below in your all-Inclusive disclosure statement (Si, Xi or both). Use one or both as appropriate. This is very important for regulatory compliance.

da Vinci S, Si-e and Si System Models
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical EndoWrist Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.  The system is indicated for adult and pediatric use except for transoral otolaryngology surgical procedures.  It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.  The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established.

da Vinci Xi System Model
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical Systems Model IS4000) is intended to assist in the accurate control of Intuitive SurgicalEndoscopicInstruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use. 

Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Product Availability
Unless otherwise noted, products featured are available for commercial distribution in the U.S. Some products may not be available worldwide and may not be used for all applications. For availability outside the U.S., please check with your local representative or distributor.

Intuitive-Provided Instruction 
Training provided by Intuitive Surgicalis limited to the use of the da Vinci Surgical System and does not replace the necessary medical training and experience required to perform surgery. The da Vinci Surgical System should be used only by surgeons who have received specific training in its use.

Intuitive Surgical facilitates peer-to-peer clinical teaching. Intuitive Surgical does not teach surgery, nor does it provide or evaluate surgical credentialing. Procedure descriptions are developed with, reviewed and approved by independent surgeons.

Intuitive Surgical-sponsored presentations, instruction and promotional materials are intended for general information only and are not intended to substitute for formal medical training or certification. da Vinci Surgical System training programs are not replacements for hospital policy regarding surgical credentialing. Certification, OR access and hospital privileges are the responsibility of the surgeon and their institutions, not that of Intuitive Surgical.

Any demonstration during Intuitive Surgical-sponsored training or instructional material on how to use the system to perform a particular technique or procedure is not the recommendation or “certification” of Intuitive Surgicalas to such technique or procedure, but rather is merely a sharing of information on how other surgeons may have used the system to perform a given technique or procedure. Clinical information and opinions expressed by training participants, including any inaccuracies or mistakes, belong to the individual. Information and opinions are not necessarily those of Intuitive Surgical, Inc.

User Responsibilities
Before performing any da Vinci® procedure, physicians are responsible for receiving sufficient training and proctoring to ensure that they have the skill and experience necessary to protect the health and safety of their patients.

Users of the da Vinci system must follow all instructions for use supplied with the system, instruments and accessories. Use of da Vinci instruments for tasks other than that for which they were designed may result in damage or breakage. Unless stated in the instructions, do not use EndoWrist instruments on cartilage, bone or hard objects. Failure to follow instructions may lead to serious injury or surgical complications for the patient, including death. Electrosurgical energy may cause burns, serious injury or complications to the patient, including death. It is important to fully understand the da Vinci System energy user interface, not exceed recommended energy levels and to use caution when working near critical anatomy.

For Important Safety Information, including indications for use and full cautions and warnings, please also refer to the product instructions for use. Read all instructions carefully. Failure to properly follow instructions, notes, cautions, warnings and danger messages associated with this equipment may lead to serious injury or complications for the patient, including death.

In the event that the da Vinci System, instruments, or accessories do not work as expected or if you are aware of a product deficiency or adverse event, please contact Intuitive Surgical Customer Service immediately. Please refer to the Customer Service contact information in the product Instructions for Use.

Intuitive Surgical promotes and facilitates the use of the da Vinci System for commercial use only in conjunction with on-label procedures set forth in the Instructions for Use. Intuitive Surgical recommends consulting your institutional policy regarding the use of cleared medical devices for off-label procedures prior to utilizing the da Vinci System.

PN 1006733 Rev D 10/2016

©2018 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders

da Vinci® Surgical System Safety

When considering surgical treatment options, many patients have concerns about safety. In particular, patients question whether da Vinci® Surgery is as safe as traditional surgery.

In fact, the da Vinci Surgical System has been used successfully in tens of thousands of minimally invasive procedures worldwide. In addition, the da Vinci System offers multiple, redundant safety features, which make the most effective, least invasive approach potentially as safe as traditional surgical methods.

First and foremost, the da Vinci System cannot be programmed, nor can it make decisions on its own. Instead, the da Vinci System requires that every surgical maneuver be performed with direct input from your surgeon.

da Vinci System surgeon console
The da Vinci System surgeon console

With da Vinci Surgery, as with traditional methods, you are under the care of at least two medical professionals: Your surgeon as well as his or her supporting team. Your surgeon requires at least one assistant at your side during surgery. This team-member assists with tasks, such as switching between instruments, to provide your surgeon with the optimal da Vinci instrument for the procedure step being performed.

Just a few feet away, your surgeon operates using the console controls. As your surgeon maneuvers the controls, da Vinci scales, filters and translates his or her wrist and finger movements into precise movements of miniaturized instruments at the patient-side cart. Tremor reduction minimizes unintended movements, which means that da Vinci instruments can move in a more precise manner than a human hand.

And because the da Vinci Patient Cart does the work of holding and repositioning the instruments and camera – and because your surgeon operates while seated — surgeons can experience much less fatigue in performing surgery with the da Vinci System.

Finally, during the course of an operation, the da Vinci System will perform millions of safety self-checks. The System is designed to be fail-safe, which means that in the event of power interruption or a safety-check failure, the System is designed to shut down safely, allowing the surgeon to remain in control of the procedure.


While clinical studies support the effectiveness of the da Vinci® System when used in minimally invasive surgery, individual results may vary. Surgery with the da Vinci Surgical System may not be appropriate for every individual. Always ask your doctor about all treatment options, as well as their risks and benefits.

Content provided by Intuitive Surgical. For more information on this topic, please visit www.davincisurgery.com

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