BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST BICOAG MACRO JAW FORCEPS

    MDR report key: 6692821 · Received July 5, 2017

    Report

    Report Number
    MW5070843
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    May 11, 2017
    Report Date
    July 5, 2017
    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

    DURING LAPAROSCOPIC BTO, THE GYRUS ACMI EVEREST BICOAG MACRO JAW FORCEPS HANDPIECE MADE A "POPPIG" SOUND AND THE JAW OF THE HANDPIECE WOULD NO LONGER CLOSE. THE DEVICE WAS REPLACED WITH ONE OF A DIFFERENT LOT NUMBER, WITH NO FURTHER ISSUES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466226 EVEREST BICOAG MACRO JAW FORCEPS LAPAROSCOPIC BICOAG FORCEPS GEI GYRUS ACMI 3640 PW303413

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR