BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEANEY-BALLANTINE FORCEPS

    MDR report key: 4232778 · Received September 12, 2014

    Report

    Report Number
    3007208013-2014-00015
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    June 2, 2014
    Report Date
    September 10, 2014
    Manufacturer
    SYMMETRY SURGICAL, INC.
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DR. SAID CLAMP TIP WAS BREAKING WHILE IN USE IN VAGINA THOUGH UTERUS WAS ALREADY OUT OF PATIENT. THEN SHE TOOK OUT CLAMP AND TIP THAT BROKE OFF. INSTRUMENT USED IN TOTAL VAGINAL HYST. DEVICE FAILED (E.G. BROKE, COULD NOT GET IT TO WORK OR STOPPED WORKING). DEVICE MALFUNCTION: THE DEVICE DID NOT DO WHAT TI WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564838 HEANEY-BALLANTINE FORCEPS FORCEPS GZX SYMMETRY SURGICAL, INC. 19-5505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51.0 YR