important-safety-information

Important Safety Information

The information provided on this website is not intended to be a substitute for a thorough discussion with your doctor about whether surgical treatment with the da Vinci Surgical System is right for you. There are risks associated with any surgical procedure and individual results may vary. Surgery with the da Vinci Surgical System may not be appropriate for every individual. if you are a patient, consult with a qualified physician familiar with the da Vinci Surgical System about treatment options that may be appropriate for your medical condition.

Indications for Use

The da Vinci Surgical System is indicated for assistance in minimally invasive urological and general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy. The da Vinci Surgical System may also be used with an auxiliary incision to perform cardiac revascularization (coronary artery bypass surgery) under certain circumstances. The System is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in its professional Instructions for Use.

Contraindications for Use

Any and all factors that would make the use of conventional minimally invasive instruments and surgical technique unadvisable also apply to the use of the da Vinci Surgical System. General contraindications to minimally invasive surgery may include bleeding disorders, history of prior surgery, pregnancy and significant cardio-pulmonary conditions.

Alternative Treatment Options

Although the da Vinci Surgical System is considered safe and effective, it may not be appropriate for every individual, as an individual's circumstances may preclude using minimally invasive techniques or suggest other treatment options. Always ask your doctor about all treatment options that may be appropriate for your medical condition, as well as their risks and benefits. If you have questions about the da Vinci Surgical System or a da Vinci procedure, consult with a qualified physician familiar with the da Vinci Surgical System. A list of physicians experienced with the da Vinci Surgical System can be found in the Surgeon Locator section.

Conversion to Non-Minimally Invasive Technique

Environmental or equipment failures may cause the da Vinci Surgical System to be unavailable and may require your doctor to convert to alternative surgical techniques. Ask your doctor about the potential risk of such conversions.

Surgeon Training

The da Vinci Surgical System should be used only by surgeons who have developed adequate robotic skills to perform the tasks associated with each procedure and who have received specific training in the use of the da Vinci Surgical System. Training provided by Intuitive Surgical is limited to product education on the da Vinci Surgical System and does not replace the necessary medical training and experience required to perform surgery.

Intuitive Surgical makes no claims as to the competency, training or licensing of the physicians listed or identified on this site. We encourage patients to investigate a surgeon's training and experience by searching the American Medical Association's (AMA) "Directory of Physicians in the U.S. " and the American Board of Medical Specialties (ABMS) "Official Directory of Board Certified Medical Specialists".

Medical Advice Disclaimer

These pages are not intended to provide medical advice or physician instruction on the appropriate use of products produced or supplied by Intuitive Surgical, its affiliates, related companies, or its licensors or joint venture partners. Information provided should not be used for diagnostic or training purposes.

If you are a physician, contact Intuitive Surgical for further information on product training. Surgeons or others who are considering using robotic-assisted surgery should only do so after successfully completing required medical training and certification as well as the relevant training mandated in the professional guidelines of their own hospital, institution, or society – including training on the use of the da Vinci Surgical System.


All surgery presents risk, including da Vinci Surgery. Results, including cosmetic results, may vary. Serious complications may occur in any surgery, up to and including death. Examples of serious and life-threatening complications, which may require hospitalization, include injury to tissues or organs; bleeding; infection, and internal scarring that can cause long-lasting dysfunction or pain. Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery. Patients should understand that risks of surgery include potential for human error and potential for equipment failure. Risk specific to minimally invasive surgery may include: a longer operative time; the need to convert the procedure to an open approach; or the need for additional or larger incision sites. Converting the procedure to open could mean a longer operative time, long time under anesthesia, and could lead to increased complications. Research suggests that there may be an increased risk of incision-site hernia with single-incision surgery. Patients who bleed easily, have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci Surgery. Other surgical approaches are available. Patients should review the risks associated with all surgical approaches. They should talk to their doctors about their surgical experience and to decide if da Vinci is right for them. For more complete information on surgical risks, safety and indications for use, please refer to http://www.davincisurgery.com/da-vinci-surgery/safety-information.php.

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PN 1002302 Rev A 04/2013

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