Indications for Use

da Vinci Xi® Surgical System

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci S® and Si® System Models

The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical EndoWrist Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use except for transoral otolaryngology surgical procedures. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established.

da Vinci S® and Si® – TransOral Robotic Surgery (TORS)

The da Vinci S, Si-e, and Si Systems are indicated for transoral otolaryngologic surgical procedures restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures. The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established. These da Vinci® Systems are not indicated for pediatric transoral otolaryngology surgical procedures. The performance characteristics of the da Vinci Surgical Systems have not been established in patients with: poor mouth openings (< 1.5 cm), advanced tumors (e.g., invading the mandible, abutting the carotid artery, requiring bone resection, etc.), dental surgery (i.e. tooth extraction).

da Vinci® Single-Site®

The Intuitive Surgical® da Vinci® Single-Site® Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) 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 and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.

The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecologic surgery procedures have not been established. This device is 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 Si Surgical System (IS3000).

Firefly®

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, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization
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 of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.

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; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.

Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci® Surgery. 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 in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to http://www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.

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