BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 4920996 · Received July 8, 2015

    Report

    Report Number
    4920996
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 8, 2015
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT UNDERGOING LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY W/BILATERAL SALPINGO-OOPHORECTOMY, POSTERIOR COLPORRHAPHY DURING WHICH THE CUTTING FORCEPS QUIT WORKING; DOCTOR GRASPED TISSUE AND THE CUTTING FORCEPS DID NOT MAKE A NOISE AND DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444122 HALO PKS CUTTING FORCEPS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC. * JF857747

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR