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RobotRisk / Intuitive Surgical / 2022-05
medical robotics · fatality

MAUDE death report 2955842-2022-11457 (da Vinci)

S5 · 05/2022 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typefatality
Date05/2022
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS5 (fatality or catastrophic loss)
ScaleMDR 2955842-2022-11457
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceopenFDA MAUDE

What happened

ON 14-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVI

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