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RobotRisk / Intuitive Surgical / 2020-12
medical robotics · injury

MAUDE injury report 2955842-2020-11369 (da Vinci)

S3 · 12/2020 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typeinjury
Date12/2020
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMDR 2955842-2020-11369
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceopenFDA MAUDE

What happened

ADDITIONAL INFORMATION CAN BE FOUND IN FIELDS: D4, D10, G4, G7, H2, H3, H6, H8, AND H10/H11. 61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED/CONFIRMED THE CUSTO

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