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RobotRisk / Intuitive Surgical / 2013
medical robotics · malfunction

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

S4 · 2013 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typemalfunction
Date2013
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS4 (serious injury, total loss, or grounding)
Scale144 deaths, 1,391 injuries, 8,061 malfunctions over 14 years, aggregate MAUDE data
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourcePLOS One

What happened

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.

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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By incident type

By severity

Intuitive Surgical vs medical robotics alternatives

medical robotics context

medical robotics: entries by year

2545082015 S2: 12015 S3: 12152016 S3: 32016 S4: 14162017 S4: 11172018 S2: 12018 S3: 12182019 S3: 33192020 S3: 1052020 S5: 3108202021 S3: 1642021 S4: 12021 S5: 3168212022 S2: 12022 S3: 1352022 S5: 10146222023 S3: 2222023 S5: 2224232024 S3: 2692024 S5: 7276242025 S3: 5042025 S5: 4508252026 S1: 12026 S2: 12026 S3: 4262026 S4: 52026 S5: 844126
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medical robotics: failure modes

medical robotics: most entries

malfunction context

malfunction: by category

malfunction: by year

malfunction: severity profile

Comparable malfunction events in medical robotics

SevDateCompanyEvent
S12026-03Keenon RoboticsRestaurant service robot malfunctions, scatters tableware
S32025Intuitive Surgical2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures
S32024-05-08NeuralinkNeuralink brain implant threads retract in first human patient
S42021-09Intuitive SurgicalLawsuit: da Vinci surgical robot burned woman's small intestine
S2Medtronic HugoField safety notice for Hugo surgeon console power supply failure
S4Intuitive SurgicalNBC News 10-year MAUDE analysis of da Vinci adverse events

Other Intuitive Surgical entries

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