da Vinci 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 U.S. Food and Drug Administration (FDA) has cleared the da Vinci ® Surgical System for use in urological 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, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also 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 us by trained physicians in an operating room environment in accordance with representative, specific procedures set forth in the 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.
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 your 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, 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.
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, please visit www.davincisurgery.com