BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENZYME

    MDR report key: 271492 · Received March 30, 2000

    Report

    Report Number
    MW1018535
    Event Type
    Other
    Date Received
    March 30, 2000
    Date of Event
    March 24, 2000
    Report Date
    March 30, 2000
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCISSOR/CAUTERY DEVICE ARCED RESULTING IN 5 SMALL BURNS TO PT'S COLON. INSPECTION OF INSTRUMENT SHOWED HOLES IN INSULATED PORT OF INSTRUMENT. HOLES APPEAR TO BE BURN HOLES. DID NOT EXIST PRIOR TO USE. TOOL IS < 3 MONTHS OLD. USED WITHOUT INCIDENT PRIOR TO THIS. EXPIRATION DATE "EVERY 3 YEARS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENZYME SWITCH BLADE HANDLE GEI GENZYME SURGICAL PRODUCTS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other