China NMPA Product Recall - Endoscopic surgical control system and accessories

The National Medical Products Administration (NMPA) announced a Class II voluntary recall on November 18, 2019, initiated by Intuitive Surgical, Inc. This recall pertains to specific batches of its Da Vinci Xi endoscopic surgical control system and accessories, registered under certificate 20183010498. The issue identified is a potential increase in friction within the instrument arm during certain movements, which could cause users to experience operational resistance, untimely instrument tip sensing, or slight vibrations. Intuitive Surgical, Inc., through its agent Intuitive Fosun Medical Device Technology (Shanghai) Co., Ltd., is responsible for this corrective action. The affected product, model IS4000, is used in various minimally invasive surgeries, including urological, general, and thoracic procedures. A crucial detail of this NMPA-regulated recall is that the specific batches impacted by this issue were not sold in China, despite the recall notice being published by the Chinese authority.