European Disclaimers for Intuitive Products

In compliance with local and regional rules and regulations, see our list of mandatory regional product disclaimers for product usage in Europe. Product descriptions and market information can be found on their respective web pages of the Intuitive website.

Da Vinci Surgical Systems

The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci X and da Vinci Xi Surgical Systems) 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 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 systems are indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures). They are intended to be used by trained physicians in an operating room environment.

The da Vinci X and da Vinci Xi Surgical Systems are class IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.


Table Motion

The da Vinci Table Motion is intended to allow the surgical staff to reposition the patient by adjusting the table without undocking the da Vinci Xi Surgical System during urologic surgical procedures, general laparoscopic surgical procedures, and gynecologic surgical procedures. It is designed to be used with a compatible operating room (OR) table.


Firefly

The da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging 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 or common hepatic duct), using near infrared imaging.


EndoWrist Instruments

EndoWrist Instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended 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.

EndoWrist Instruments are class IIa and class IIb medical device CE marked (CE2460) under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.


Vessel Sealer Extend

The Vessel Sealer Extend is a bipolar electrosurgical sealing and cutting instrument for use with the da Vinci Xi and da Vinci X Surgical Systems and the compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Vessel Sealer Extend is a class IIb medical device CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.


SynchroSeal

SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The SynchroSeal is a class IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.


SureForm Family

The SureForm 60 and SureForm 45, SureForm 60 and SureForm 45 Reloads are intended to be used with a compatible da Vinci Surgical System for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The devices can be used with staple line or tissue buttressing material (natural or synthetic).

The SureForm 60 and SureForm 45, SureForm 60 and SureForm 45 Reloads are class IIa and IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.


Force Bipolar

The EndoWrist Force Bipolar is intended to be used with compatible systems for endoscopic manipulation of tissue, including dissection, grasping, retraction, and bipolar coagulation of tissue.

The EndoWrist Force Bipolar is a class IIb medical device CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.


ERBE VIO dVa

The ERBE VIO dV with Accessories electrosurgical unit is intended to deliver High Frequency (HF) current for the cutting and/or coagulation of tissue.

The ERBE VIO dV is a class IIb medical device CE marked (CE 0124) under the European Medical Devices Directive (93/42/EEC) manufactured by ERBE Elektromedizin GmbH. Refer to Instructions For Use before use.


E-100 Electrosurgical Generator

The E-100 Electrosurgical Generator is an electrosurgical unit (ESU) intended to deliver high-frequency energy (HF) for cutting, coagulation and vessel sealing of tissues.

The E-100 Electrosurgical Generator is a class IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.