Surgical Risks

Risks associated with hysterectomy, benign (removal of the uterus and possibly nearby organs) include injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problems (scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates), injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), vaginal fistula (abnormal hole from the vagina into the urinary tract or rectum), vaginal tear or deep cut. Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Important Safety Information

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 and associated risks in order to make an informed decision.

Serious complications may occur in any surgery, including da Vinci surgery, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques which could result in a longer operative time and/or increased complications. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to www.intuitive.com/safety.

Individuals' outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics and/or surgeon experience.

Da Vinci Xi System Precaution Statement

The demonstration of safety and effectiveness for the specific procedure(s) discussed in this material was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Medical Advice and Locating a Doctor

Patients should talk to their doctor to decide if da Vinci surgery is right for them. Other options may be available and appropriate. Only a doctor can determine whether da Vinci surgery is appropriate for a patient’s situation. Patients and doctors should review all available information on both non-surgical and surgical options in order to make an informed decision.

Surgeons who perform surgery using the da Vinci system can be found using the Surgeon Locator. Intuitive Surgical provides surgeons with training on the use of the da Vinci system but does not certify, credential or qualify the surgeons listed in the Surgeon Locator.

Published Evidence

In order to provide benefit and risk information, Intuitive Surgical reviews the highest available level of evidence on procedures named above. Intuitive Surgical strives to provide a complete, fair and balanced view of the clinical literature. However, our materials should not be seen as a substitute for a comprehensive literature review for inclusion of all potential outcomes. We encourage patients and physicians to review the original publications and all available literature in order to make an informed decision. Clinical studies are typically available at pubmed.gov.

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