FDA 483 - Intuitive Surgical, Inc. - March 06, 2020

An FDA inspection of Intuitive Surgical, Inc. in Sunnyvale, CA, a medical device manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately maintain complaint files, particularly regarding investigations into patient deaths and device retrieval, and did not clearly identify MDR-reportable events. Additionally, issues were noted with contamination control procedures in a cleanroom environment and with the timely and complete submission of Medical Device Reports (MDRs).