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.
Firefly® Fluorescence Imaging
The da Vinci® Fluorescence Imaging Vision System (Firefly® Fluorescence Imaging) is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow, and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for adjunctive use only, in conjunction with standard of care white light and when indicated, with intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Intuitive’s ICG packs are available for sale in the U.S. ONLY. Intuitive’s ICG packs are cleared for commercial distribution in the U.S. for use in combination with the fluorescence-capable da Vinci Si HD vision system and Firefly integrated hardware. Intuitive-distributed ICG contains necessary directions for use of ICG with Firefly Fluorescence Imaging. Using generic ICG with Firefly Fluorescence Imaging is considered off-label and is not recommended. Anaphylactic deaths have been reported following ICG injection during cardiac catheterization. Total ICG dosage should not exceed 2 mg/kg per patient. Anaphylactic or urticarial reactions have been reported in patients with or without histories of allergy to iodides.
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