FDA 483 - Intuitive Surgical, Inc. - August 27, 2021

An FDA inspection of Intuitive Surgical, Inc. in Sunnyvale, CA, revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, medical device reporting (MDR), and complaint handling. The firm failed to adequately document CAPA activities, identify MDR reportable events, establish proper complaint procedures, and maintain complete complaint files. These issues were linked to device malfunctions, patient injuries, and deaths involving their surgical instruments, including cautery hooks, spatulas, and robotic staplers.