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RobotRisk / Intuitive Surgical / 2023-05
medical robotics · injury

MAUDE injury report 2955842-2023-15153 (da Vinci)

S3 · 05/2023 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typeinjury
Date05/2023
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMDR 2955842-2023-15153
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceopenFDA MAUDE

What happened

BASED ON THE INFORMATION GATHERED, THE CAUSES OF THE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ARTICLE CITATION: JEONG, S.Y.; KIM, K.; RYU, J.W.; CHA, J.; PARK, S.T.; PARK, S.H. COMPARISO

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