14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)

Record

Summary

A peer-reviewed retrospective study of FDA MAUDE adverse event data covering 2000-2013 (the vast majority involving da Vinci systems, the dominant robotic surgery platform) found 144 reported deaths, 1,391 patient injuries, and 8,061 device malfunctions associated with robotic surgery.

Primary source

Supporting source rows (1)

Date	Supporting source row	Publisher	Link
~2013	14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)	PLOS One	PLOS One

Intuitive Surgical other incidents timeline

Medical robotics context

malfunction context

Intuitive Surgical industry position

Related incidents

Other Intuitive Surgical entries

• 18 Mar 2026 - FDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries
• 11 Mar 2026 - Class I recall of da Vinci SureForm stapler reloads after patient death
• 26 Feb 2025 - Class II recall of da Vinci 5 foot pedal over spring failure
• ~2025 - 2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures
• ~Sep 2021 - Lawsuit: da Vinci surgical robot burned woman's small intestine
• not documented - Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying
• not documented - NBC News 10-year MAUDE analysis of da Vinci adverse events

Report a correction

Open a prefilled GitHub issue