BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS 5MM X 33MM

    MDR report key: 3835680 · Received May 21, 2014

    Report

    Report Number
    MW5036267
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 13, 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

    GYRUS ACMI HALO PKS CUTTING FORCEPS WOULD NOT FUNCTION. GENERATOR READ "HANDPIECE STUCK". THIS WAS REPLACED WITH A SUBSEQUENT "LIKE" DEVICE WHICH FUNCTIONED WITHOUT INCIDENT. DIAGNOSIS OR REASON FOR USE: RIGHT LSO. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301756 HALO PKS CUTTING FORCEPS 5MM X 33MM CUTTING FORCEPS GEI GYRUS ACMI HACF0533 JF829592

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR