BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 3459122 · Received October 8, 2013

    Report

    Report Number
    2183680-2013-00051
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 4, 2013
    Report Date
    September 4, 2013
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, A GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TWO OF THE SAME LOT DEVICE MALFUNCTIONED, IT CREATED A DELAY AND CAUSED EXCESSIVE BLEEDING. A THIRD WAS USED FROM A DIFFERENT LOT AND FUNCTIONED NORMALLY, THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. (OTHER DEVICE ON MFR. REPORT # 2183680-2013-00052).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510678 PKS CUTTING FORCEPS PKS CUTTING FORCEPS GEI GYRUS MEDICAL, INC. 920005PK JF67754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention