BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 1915265 · Received November 2, 2010

    Report

    Report Number
    2183680-2010-00050
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 2, 2010
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED, THE FLARE IS DETACHED FROM THE CUTTING FORCEPS AND RETURNED WITH THE DEVICE, THE FLARE IS SPLIT LENGTH WISE, CANNOT SEE ANY RESIDUAL ADHESIVE ON THE FLARE, MFR DATE OF THE DEVICE INDICATES IT WAS PRODUCED PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTION FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    DURING A PROCEDURE, WHEN THE SURGEON PULLED THE TRIGGER TO OPEN THE JAWS, A PIECE FELL OFF IN THE PT. HE RETRIEVED THE PIECE AND FINISHED THE PROCEDURE WITH ANOTHER LIKE INSTRUMENT WITHOUT ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS CUTTING FORCEPS CUTTING FORCEPS GEI GYRUS MEDICAL INC 920005PK 78926AB

    Patients

    Seq Age Sex Outcome Treatment
    1