BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST BICOAG MACRO JAW FORCEPS 5MM X 45 CM

    MDR report key: 3880341 · Received June 13, 2014

    Report

    Report Number
    MW5036650
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    GYRUS/ACMI
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE GYRUS ACMI EVEREST BICOAG MACRO JAW FORCEPS WOULD NOT COAGULATE. THIS WAS REPLACED WITH A "LIKE" DEVICE WHICH FUNCTIONED WITHOUT ISSUE. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC BTC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349176 EVEREST BICOAG MACRO JAW FORCEPS 5MM X 45 CM EVEREST BICOAG MACRO JAW FORCEPS 5MM X 45 CM GEI GYRUS/ACMI 3640 JF829942

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR