BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS CUT FORCEPS, 5MM, 33CM, 9-PIN

    MDR report key: 3824484 · Received April 3, 2014

    Report

    Report Number
    2951238-2014-00164
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GYRUS ACMI INC
    Product Code
    HFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTING FORCEPS WERE RETURNED TO OLYMPUS FOR EVALUATION. EVALUATION CONFIRMED THE COMPLAINT. VISUAL INSPECTION FOUND THE INSULATION DAMAGED ON ALL FOUR ELECTRODES AND THE FLARE CRACKED IN FOUR PLACES WHERE THE ELECTRODE HUMPS START TO ENTER THE SHAFT WHEN THE JAWS WERE CLOSED. THE JAWS OPEN/CLOSE, THE BLAD ADVANCES/RETRACTS AND THE LOCK FUNCTIONS AS DESIGNED. THE BARE SPORTS ON THE ELECTRODES WERE SHORTING CUT ON THE SHAFT WHERE THE FLARE WAS CRACKED. THE ROOT CAUSE WAS INCONCLUSIVE AND UNABLE TO BE DETERMINED. THE DEVICE HISTORY RECORD SHOWED NO DISCREPANCIES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY THE PHYSICIAN WASN'T AWARE THAT THE DEVICE WAS INTERMITTENTLY COAGULATING AND WOULD CUT TISSUE AS THE PT HAD A VERY LARGE COAGULATION. THE PT LOST 100CC'S OF BLOOD FROM A BLEEDER AND HAD TO BE GIVEN A UNIT OF BLOOD FROM A BLEEDER AND HAD TO BE GIVEN A UNIT OF BLOOD. ANOTHER DEVICE WAS OPENED WHICH ALSO FAILED. THE CASE WAS FINISHED USING A THIRD DEVICE. OLYMPUS HAS ATTEMPTED TO FOLLOW UP TO OBTAIN FURTHER INFO REGARDING THE PT'S CONDITION BUT NO INFO HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202989 PKS CUT FORCEPS, 5MM, 33CM, 9-PIN FORCEPS HFB GYRUS ACMI INC 920005PK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 920005PK/ PKS CUT/ FCP, 5MM/33CM 9-PIN (5/PK)