BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON FFPF EMC

    MDR report key: 1230569 · Received November 13, 2008

    Report

    Report Number
    2428235-2008-00007
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ELLMAN INTL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K972072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL OF THE EMC GENERATOR, WE FOUND THAT THE EMC HAD BEEN IMPROPERLY MODIFIED BY SOMEONE OUTSIDE OF ELLMAN INTL. SEVERAL CRITICAL ELECTRONIC COMPONENTS HAD BEEN REPLACED AND THE CIRCUITRY MODIFIED. AS A RESULT, THE MACHINE WAS NOT FUNCTIONING PROPERLY AND WAS SPARKING AT LOW DIAL SETTINGS. WE NOTIFIED MEDICARE THAT THE PROPER METHOD FOR REPAIRING ELLMAN GENERATORS IS TO SEND THEM BACK TO THE FACTORY FOR REPAIR.

    Description of Event or Problem · 1

    WE WERE NOTIFIED IN 2008, BY A DISTRIBUTOR THAT TWO PTS WERE BURNED DURING LEEP PROCEDURES. THE PROCEDURES OCCURRED AT HOSP IN ANOTHER COUNTRY. THE SAME SURGITRON EMC DEVICE WAS USED ON BOTH PTS. NO ADDITIONAL INFO IN THE INCIDENTS WERE AVAILABLE. WE ASKED TO HAVE THE EMC RETURNED. FOUR MONTHS PRIOR, MEDICARE, INITIATED THE PROCESS TO RETURN THE EMC. WE AGAIN ASKED FOR DETAILS OF THE PROCEDURE AND INJURIES. AS OF THE TIME OF FILING THIS REPORT, WE HAVE YET TO RECEIVE DETAILS OF THE PT INCIDENTS. WE RECEIVED THE EMC IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON FFPF EMC GEI ELLMAN INTL, INC. EMC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention