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RobotRisk / Asensus Surgical / 2023-09

MAUDE injury report 3007593944-2023-00011 (Senhance)

S3 · 09/2023 · Asensus Surgical

Record

CompanyAsensus Surgical
Categorymedical robotics
Typeinjury
Date09/2023
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMDR 3007593944-2023-00011
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceopenFDA MAUDE

What happened

BASED ON THE COMPLAINT DETAILS (B)(4) THE PATIENT EXPERIENCED FEVER, LEUKOCYTOSIS, ELEVATED CRP, AND NOTED PURULENT DISCHARGE FROM THE ANUS. A DIGITAL EXAM REVEALED ANASTOMOTIC LEAKAGE. PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (METRONIDAZOLE-500 MG 3X DAILY; CEFUROXIME-1 G) AN

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