BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS G400 GENERATOR

    MDR report key: 1213674 · Received October 23, 2008

    Report

    Report Number
    2183680-2008-00029
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 23, 2008
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    PMA / PMN Number
    K050550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENERATOR WAS TESTED EXACTLY AS IT WAS RETURNED TO US, NO ADJUSTMENTS WERE DONE TO THE GENERATOR. NO INSTRUMENTS WERE RETURNED WITH THE GENERATOR, SO THE GENERATOR WAS TESTED WITH A 5 MM, 33 CM, CUTTING FORCEPS, THE SAME TYPE AS WAS USED WHEN THE PROBLEM OCCURRED. A 10 MM, 33 CM CUTTING FORCEPS WAS ALSO TESTED. THE DEVICES PERFORMED WITH TONES AND ASTERISKS DROPPING, AS EXPECTED. THE OUTPUTS WERE THEN TESTED AND ALL VOLTAGES WERE WITHIN THE MFR'S TOLERANCES. WE WERE UNABLE TO CONFIRM THE REPORTED PROBLEM. THERE WERE NO PROBLEMS FOUND DURING OUR EVAL.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, WHILE USING PKS LYONS CUTTING FORCEPS, 5 MM, 33 CM, THE GYRUS G400 GENERATOR STOPPED WORKING. EXCESSIVE BLEEDING ENSUED AND THE SURGEON HAD TO REMOVE AN OVARY TO FINISH THE PROCEDURE. THE PT HAS RECOVERED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS G400 GENERATOR GYRUS G400 GENERATOR GEI GYRUS ACMI, INC. 777000

    Patients

    Seq Age Sex Outcome Treatment
    1