FDA 483 - Intuitive Surgical, Inc. - December 14, 2023

An FDA inspection of Intuitive Surgical, Inc. in Sunnyvale, CA, a medical device manufacturer, revealed a significant quality system deficiency related to its corrective and preventive action (CAPA) procedures. Specifically, the company failed to adequately investigate and establish root causes for a recall involving a loose Universal Surgical Manipulator (USM) carriage, indicating a breakdown in their CAPA process. This issue suggests a need for improved design control and investigational practices to prevent recurrence.