China NMPA Product Recall - Endoscopic surgical control system and accessories da Vinci Xi Surgical System

On April 12, 2022, the National Medical Products Administration (NMPA) issued a notice regarding a voluntary product recall initiated by Intuitive Surgical, Inc. The recall stems from a report by Intuitive Fosun Medical Device Technology (Shanghai) Co., Ltd., identifying a significant safety concern. The primary issue involves specific models and batches of the endoscopic surgical control system and accessory da Vinci Xi Surgical System (Registration Certificate No.: 20183010498). It was determined that the probability of injury events caused by tissue extrusion during firing of these devices now surpasses the existing risk control level. This elevated risk profile prompted the manufacturer to take corrective action. Under the regulatory oversight of the NMPA, Intuitive Surgical, Inc. is conducting a voluntary recall of the affected medical devices. This essential action is being taken to address the identified safety issue, minimize potential patient harm, and ensure the continued safe use of medical equipment. Further details on the specific models and batches impacted are available in the accompanying "Medical Device Recall Event Report Form."