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FDA Clearance

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 (with the exception of transoral otolaryngology surgical procedures in pediatric patients).

The da Vinci Surgical System is intended for use by trained physicians in an operating room environment in accordance with representative, specific procedures set forth in the Professional Instructions for Use.

Representative Uses: The da Vinci System has been successfully used in the following procedures, among others:

* Radical prostatectomy, pyeloplasty, cystectomy, nephrectomy, ureteral reimplantation
* Cholecystectomy, Nissen fundoplication, Heller myotomy, gastric bypass, donor nephrectomy, adrenalectomy, splenectomy, bowel resection and other colorectal procedures
* Oropharyngeal, laryngeal and hypopharyngeal resections and oral cavity resections
* Hysterectomy, myomectomy and sacrocolpopexy
* Internal mammary artery mobilization and cardiac tissue ablation
* Mitral valve repair, endoscopic atrial septal defect closure
* Mammary to left anterior descending coronary artery anastomosis for cardiac revascularization with adjunctive mediastinotomy

PN 874174 Rev A 08/11

All surgery presents risk, including da Vinci® Surgery and other minimally invasive procedures.  Serious complications may occur in any surgery, up to and including death. Examples of serious or life-threatening complications which may require hospitalization include injury to tissues or organs, bleeding, infection or 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. Risks of surgery also include potential for equipment failure and human error. Risks specific to minimally invasive surgery may include: A long operation and time under anesthesia, conversion to another technique or the need for additional or larger incisions.  If your surgeon needs to convert the procedure, it could mean a long operative time with additional time under anesthesia and increased complications. Temporary pain or discomfort may result from pneumoperitoneum, the presence of air or gas in the abdominal cavity used by surgeons in minimally invasive surgery. Research suggests that there could be an increased risk of incision-site hernia with single-incision surgery. Results, including cosmetic results, may vary.  Patients who bleed easily, who have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci® Surgery. For more complete information on surgical risks, safety, and indications for use, please refer to http://www.davincisurgery.com/safety/. Patients should talk to their doctors about their surgical experience and to decide if da Vinci Surgery is right for them. Other options may be available. Intuitive Surgical reviews clinical literature from the highest level of evidence available to provide benefit and risk information about use of the da Vinci Surgical System in specific representative procedures. We encourage patients and physicians to review all available information on surgical options and treatment in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.

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