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.
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.
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.
Single-Site® technology for the da Vinci Xi® Surgical System
The Intuitive Surgical da Vinci Xi Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site port.
The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecological surgery procedures have not been established. The da Vinci Single-Site Instruments and Accessories are only intended to be used for single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and the da Vinci Xi Surgical System (IS4000). There may be an increased risk of incision-site hernia with single-incision surgery.
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