da Vinci Surgery
 

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PN 1002358 Rev A 04/2013

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.

When Is Single-Site Technology Used and What Are the Risks?

da Vinci Surgery with Single-Site® Instruments is cleared for use in gallbladder removal, and for hysterectomy and ovary removal for benign conditions. Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci Surgery, including da Vinci Surgery with Single-Site Instruments. There may be an increased risk of incision-site hernia with single-incision surgery, including Single-Site surgery with the da Vinci System. Single-Site® Instruments for the da Vinci® Si System bear the CE mark. This device is cleared for commercial distribution in the U.S. for laparoscopic cholecystectomy, and for hysterectomy and salpingo-oophorectomy for benign conditions.

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