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RobotRisk / Intuitive Surgical / 2025
medical robotics · malfunction

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

S3 · 2025 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typemalfunction
Date2025
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
Scale420.1 reports per 100,000 procedures; 3.1 deaths per 100,000 procedures, aggregate MAUDE data, most recent decade
Confidencehigh
VerificationCited source on file; not independently re-verified
SourceJournal of Robotic Surgery

What happened

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.

Intuitive Surgical record context

Entries by year and severity

2374742020 S3: 842020 S5: 387202021 S3: 1292021 S4: 12021 S5: 3133212022 S3: 1202022 S5: 10130222023 S3: 1882023 S5: 2190232024 S3: 2452024 S5: 7252242025 S3: 4702025 S5: 4474252026 S3: 3812026 S5: 838926
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malfunction context

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malfunction: severity profile

Comparable malfunction events in medical robotics

SevDateCompanyEvent
S12026-03Keenon RoboticsRestaurant service robot malfunctions, scatters tableware
S32024-05-08NeuralinkNeuralink brain implant threads retract in first human patient
S42021-09Intuitive SurgicalLawsuit: da Vinci surgical robot burned woman's small intestine
S42013Intuitive Surgical14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)
S2Medtronic HugoField safety notice for Hugo surgeon console power supply failure
S4Intuitive SurgicalNBC News 10-year MAUDE analysis of da Vinci adverse events

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