BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS OMNI INSTRUMENT, 33CM

    MDR report key: 1634347 · Received March 11, 2010

    Report

    Report Number
    2183680-2010-00010
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K081766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL TESTING WAS CONDUCTED WITH THE DEVICE. AN INTERMITTENT ELECTRICAL OPEN WAS OBSERVED. THE COAGULATION FUNCTION WOULD START AND STOP WHEN THE COAGULATION POWER WAS APPLIED. THIS MAY HAVE LED TO THE REPORTED POOR COAGULATION FUNCTION OF THE DEVICE. THE ROOT CAUSE OF THIS FAILURE MODE IS STILL UNDER INVESTIGATION. A REVIEW OF THE BUILD RECORDS FOR THIS DEVICE LOT SHOWS NO DISCREPANCIES WITH THE BUILD.

    Description of Event or Problem · 1

    DURING A LAP BSO PROCEDURE USING A PKS OMNI INSTRUMENT, THE DEVICE WOULD NOT COAGULATE. THE SURGEON DID TRIPLE SEALS, AND STILL THE VESSELS AND SURROUNDING TISSUE WOULD SEEP. THE SURGEON WHO IS VERY COMPETENT AND A LONG TIME USER OF CUTTING FORCEPS, USED THE SAME DEVICE TO COMPLETE THE CASE, WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS OMNI INSTRUMENT, 33CM PKS OMNI INSTRUMENT, 33CM GEI GYRUS MEDICAL INC. 970010PC 123856IB

    Patients

    Seq Age Sex Outcome Treatment
    1