BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G400 GENERATOR, GYRUS

    MDR report key: 1883183 · Received October 20, 2010

    Report

    Report Number
    9617070-2010-00019
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    July 28, 2010
    Report Date
    October 20, 2010
    Manufacturer
    GYRUS MEDICAL, LTD.
    Product Code
    GEI
    PMA / PMN Number
    K05055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED. ANALYSIS FOUND THAT ALL VOLTAGES WERE WITHIN MFR SPECS BEFORE ANY ADJUSTMENTS WERE MADE. THE GENERATOR WAS THEN TESTED WITH A J-HOOK ON SAMPLES OF TISSUE. THE DEVICE PERFORMED AS EXPECTED USING THE CUSTOMER'S GENERATOR. THE GENERATOR WAS THEN REWORKED BY UPGRADING THE SOFTWARE TO VERSION 2.03 PER MFR REWORK INSTRUCTIONS (B)(4). THE UNIT WAS THEN CLEANED, ELECTRICALLY CHECKED, RF OUTPUTS CHECKED, AND CURRENT LEAKAGE TESTED AS PER TEST PROCEDURE (B)(4).

    Description of Event or Problem · 1

    DURING A LAVH PROCEDURE, THE G400 GENERATOR WAS USED IN A CASE WHICH RESULTED IN A HOLE CUT IN THE PT'S BLADDER. THIS HOLE WAS NOT SEEN AT THE TIME AND THE CASE WAS COMPLETED WITHOUT INCIDENT. SEVERAL DAYS LATER THE PT RETURNED TO THE DOCTOR'S OFFICE AND A FOLEY WAS PUT IN DURING THE OFFICE VISIT IN AN ATTEMPT TO REPAIR THE HOLE. APPROX 25 DAYS LATER THE PT WAS ADMITTED AT A DIFFERENT FACILITY FOR AN OPEN PROCEDURE TO REPAIR THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G400 GENERATOR, GYRUS GYRUS PK GENERATOR GEI GYRUS MEDICAL, LTD. 777000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization