BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS 5MM/33CM

    MDR report key: 3111463 · Received May 8, 2013

    Report

    Report Number
    MW5030107
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 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

    THE GYRUS (B)(4) HALO PKS CUTTING FORCEPS WAS NOT COAGULATING THE WHOLE TIME THE HAND PIECE WAS ACTIVATED. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202246 HALO PKS CUTTING FORCEPS 5MM/33CM CUTTING FORCEPS GEI GYRUS ACMI HACF0533 JF541514

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR