Remanufactured EndoWrist Long Tip Forceps (420048)

The Remanufactured EndoWrist Long Tip Forceps is a surgical instrument used with da Vinci S and Si robotic surgical systems for grasping and manipulating tissue during minimally invasive procedures including urologic, gynecologic, general laparoscopic, thoracoscopic, and otolaryngology surgical procedures. The device is intended for use by trained physicians in an operating room.

The remanufactured Long Tip Forceps have identical technological characteristics to the predicate OEM device, including the same design, materials, chemical composition, principle of operation, energy source, performance, and host system compatibility. The use counter has been reset to permit an additional controlled set of uses.

Testing included life testing to verify device performance and durability, electrical safety evaluation per IEC 60601-1, biocompatibility testing per ISO 10993-1, reprocessing validation per OEM instructions, and cybersecurity assessment per FDA guidance on Cybersecurity in Medical Devices.

The remanufactured device is substantially equivalent because it has identical intended use, technological characteristics, and performance characteristics as the predicate OEM Long Tip Forceps with no modifications to mechanical design, materials, or dimensions. A comprehensive hazard assessment and risk analysis of the remanufacturing process was performed, with actions taken to address identified risks through appropriate testing. No questions of safety or efficacy were raised by the testing results.