BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 3131162 · Received May 22, 2013

    Report

    Report Number
    MW5030283
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    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

    HALO PKS CUTTING FORCEPS WOULD NOT COAGULATE EVEN AFTER DISCONNECTING AND RECONNECTING DEVICE. ANOTHER LIKE DEVICE WAS UTILIZED WITHOUT PROBLEMS. REASON FOR USE: LAPAROSCOPIC ROBOTIC TOTAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226827 HALO PKS CUTTING FORCEPS CUTTING FORCEPS, 5MM/33CM GEI GYRUS/ACMI HACF0533 JF534280

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR