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

Intuitive Surgical, Inc. has initiated a voluntary recall of its endoscopic surgical control system and accessories, specifically the da Vinci Xi Surgical System. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical safety concern. The recall stems from the potential for damage to the robotic arm's cannula support, which could cause deformation of the ball screw within the robotic arm insertion shaft. Such deformation poses a risk of the instrument holder moving unpredictably along its insertion path during surgical procedures. The manufacturer, Intuitive Surgical, Inc., identified this issue, prompting the voluntary recall. The NMPA has classified this as a "Recall" level event, indicating the seriousness of the potential risk. It is important to note that the specific products implicated in this recall were not imported into China. Detailed information regarding affected models, specifications, and batches is available in the accompanying "Medical Device Recall Event Report Form." This proactive measure by Intuitive Surgical underscores a commitment to patient safety and product integrity.