2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures

Record

Summary

A peer-reviewed analysis of MAUDE data from 2015-2025 found a rate of 420.1 adverse event reports per 100,000 da Vinci procedures, including 55.2 injuries, 3.1 deaths, 21.8 conversions to open surgery, and 2.1 procedure abortions per 100,000 procedures.

Primary source

Supporting source rows (1)

Date	Supporting source row	Publisher	Link
~2025	2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures	Journal of Robotic Surgery	Journal of Robotic Surge

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
• ~Sep 2021 - Lawsuit: da Vinci surgical robot burned woman's small intestine
• ~2013 - 14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)
• 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

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