Important Information for Patients
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. Risks specific to minimally invasive surgery may include: a longer operative time, the need to convert the procedure to other surgical techniques, the need for additional or larger incision sites, a longer operation or longer time under anesthesia than your surgeon originally predicts. 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 DavinciSurgery.com.
da Vinci® Single-Site® Surgery
da Vinci Surgery with Single-Site® Instruments and accessories is cleared for use in gallbladder removal, and for hysterectomy and ovary removal for benign conditions. Patients who bleed easily, have abnormal blood clotting, are pregnant or morbidly obese are not candidates for minimally invasive surgery, including da Vinci Surgery with Single-Site® Instruments. The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery procedures have not been established.
The Enabling Technology: da Vinci ® Surgical System with Single-Site® Technology
The da Vinci Surgical System is designed to provide surgeons with enhanced capabilities, including high definition 3D vision and a magnified view. Your doctor controls the da Vinci System, which translates his or her hand movements into smaller, more precise movements of tiny instruments inside your body.
Though it is often called a “robot,” da Vinci cannot act on its own. Surgery is performed entirely by your doctor. Together, the da Vinci System and Single-Site® instruments allow your doctor to perform gallbladder surgery through a single incision, similar to single incision traditional laparoscopy. As a result, you may be able to get back to life without the usual recovery following major surgery.
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