Important Safety Information
Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain.
Risks specific to minimally invasive surgery, including da Vinci® Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; a longer operative time, the need to convert to an open approach, or the need for additional or larger incision sites. Converting the procedure could result in a longer operative time, a longer time under anesthesia, and could lead to increased complications. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments.
Individual surgical results may vary.
Instrument & Accessory Care
It is the responsibility of the owner of the da Vinci® Surgical System to properly train and supervise its personnel to ensure that the instruments and accessories are properly cleaned, disinfected and sterilized as required by the User’s Manual. The da Vinci products should not be used in a clinical setting unless the institution has verified that these products are properly processed in accordance with the da Vinci System User’s Manual.
Vessel Sealer Extend
The EndoWrist® Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci surgical system and the ERBE VIO® dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
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