BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33CM PKS CUTTING FORCEPS, 5MM

    MDR report key: 1356129 · Received February 26, 2009

    Report

    Report Number
    2183680-2009-00008
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    January 28, 2009
    Report Date
    February 26, 2009
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED IN VERY CLEAN CONDITION. JAWS OPEN AND CLOSE SMOOTHLY AND CLOSE IN PARALLEL WITH ONE ANOTHER. ELECTRODE INSULATION IS INTACT, FLARE IS IN PLACE. DEVICE ACTIVATED TO THE CORRECT GENERATOR DEFAULT, VP3-35. THE DEVICE ACTIVATED, COAGULATED AND CUT NUMEROUS TIMES WITH NO DEGRADATION OF COAG FUNCTION OBSERVED. THE DEVICE OPERATES ACCORDING TO MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 1

    THREE DEVICES WERE USED IN ONE PROCEDURE. SEE ATTACHED COPIES OF MEDWATCH #'S 2183680-2009-00009 & 2183680-2009-00010, WHICH ARE THE OTHER TWO DEVICE REPORTS. DURING A LYSIS OF ADHESIONS LAPARASCOPIC PROCEDURE, THE CUTTING FORCEPS DID NOT BURN PROPERLY, SO THEY UNPLUGGED IT AND PLUGGED IT IN A GAIN, AND IT STILL WOULD NOT WORK. THE SURGEON USED THE DEVICE ON ANOTHER GENERATOR WITH THE SAME RESULT. THIS PROCESS WAS REPEATED WITH ANOTHER TWO DEVICES (SEE ADDITIONAL MEDWATCH REPORTS). THERE WAS NO INJURY TO THE PATIENT, BUT IT PROLONGED THE PROCEDURE FOR ONE HALF HOUR SO THAT THE PATIENT WAS UNDER ANESTHETIC LONGER. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE FACILITY AS TO HOW THE PROCEDURE WAS COMPLETED, AND WE WERE ONLY TOLD THAT ANOTHER DEVICE WAS USED, THEY DID NOT SPECIFY WHICH DEVICE IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33CM PKS CUTTING FORCEPS, 5MM PKS CUTTING FORCEPS, 33CM, 5MM GEI GYRUS MEDICAL INC. 920005PK 8171069

    Patients

    Seq Age Sex Outcome Treatment
    1