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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.
The EndoWrist® Stapler Cannula Seal is intended to maintain insufflation, and serves as a port of entry when used with the compatible Intuitive Surgical cannulae.
The EndoWrist® Stapler 30 for the da Vinci Xi® System (IS4000) is not compatible for use with the da Vinci, da Vinci S, or da Vinci Si Surgical System. The EndoWrist Stapler 30, and EndoWrist Stapler 30 Reloads for the da Vinci Xi System are intended to be used with the da Vinci Xi Surgical System (IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple-line or tissue-buttressing materials.
The EndoWrist Stapler 30 and EndoWrist Stapler 30 Reloads for the da Vinci Xi System should not be used on tissue such as the liver or spleen, where tissue compressibility is such that clamping of the instrument would be destructive. Do not use the EndoWrist Stapler 30 or EndoWrist Stapler 30 Reloads for the da Vinci Xi System on the aorta.