BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 4034156 · Received August 20, 2014

    Report

    Report Number
    MW5037878
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 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 HALO PKS CUTTING FORCEPS HANDPIECE WOULD NOT FUNCTION. THE GENERATOR WAS TURNED OFF AND BACK ON AND THE HANDPIECE STILL WOULD NOT FUNCTION. THE HANDPIECE WAS EXCHANGED AND THERE WERE NO FURTHER ISSUES. DIAGNOSTIC LAPAROSCOPY, LOA, LSO, FULGURATION-ENDOMETRIOSIS. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503794 HALO PKS CUTTING FORCEPS HALO CUTTING FORCEPS GEI GYRUS ACMI HACF0533 JF841745

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR