BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 3421994 · Received October 16, 2013

    Report

    Report Number
    2183680-2013-00049
    Event Type
    Injury
    Date Received
    October 16, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 17, 2013
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, TWO DEVICES WERE USED, THE FIRST ONE HAD NO POWER, THE SECOND DEVICE EXHIBITED INTERMITTENT COAG FUNCTION. A PERFORATED BLADDER WAS REPORTED. A UROLOGIST WAS CALLED IN TO REPAIR THE BLADDER. THE EXACT CAUSE OF THE BLADDER PERFORATION IS UNK. (SEE MFR REPORT #2183680-2013-00050 FOR THE SECOND DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529659 HALO PKS CUTTING FORCEPS HALO PKS CUTTING FORCEPS GEI GYRUS MEDICAL INC HACF0533 JF776017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R