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RobotRisk / Intuitive Surgical / 2023-01

MAUDE injury report 2955842-2023-10033 (da Vinci)

S3 · 01/2023 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typeinjury
Date01/2023
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMDR 2955842-2023-10033
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceopenFDA MAUDE

What happened

IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE FOR A 4CM LESION WITH THE DIAGNOSIS OF A PRIMARY LUNG CANCER. THERE WERE DENSE ADHESIONS BETWEEN A CALCIFIED LYMPH NODE AND THE INTERLOBAR PULMONARY ARTERY (PA)

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