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Important Safety Information
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 and associated risks in order to make an informed decision.
Serious complications may occur in any surgery, including da Vinci Surgery, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques which could result in a longer operative time and/or increased complications. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to www.davincisurgery.com/safety and www.intuitive.com/safety.
Individual surgical results may vary.
da Vinci Surgical Systems
The da Vinci Surgical System are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection 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 (except for trans-oral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment.
The da Vinci Surgical Systems are class IIb medical devices CE marked (CE0543) under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
The Intuitive Surgical Stapler SureForm 60, Stapler SureForm 60 reloads, and other stapler accessories are intended to be used with a compatible da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The SureForm™ Stapler 60 and SureForm 60 Reloads are class IIa and IIb medical devices CE marked (CE0543) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
Product names are trademarks or registered trademarks of Intuitive Surgical, or of their respective holders.