BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR

    MDR report key: 4836270 · Received June 10, 2015

    Report

    Report Number
    1717344-2015-00390
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 19, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED FORCEFX-8C GENERATOR WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION FOUND THAT THE REM TEST FOR A SINGLE PAD FAILED. THE CAUSE OF THE REM FAILURE WAS ISOLATED TO A BROKEN SWITCH WITHIN THE REM ADAPTER ASSEMBLY; BUT THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. THIS SWITCH IS USED BY THE GENERATOR TO DETERMINE WHICH STYLE OF RETURN ELECTRODE IS BEING USED (SPLIT OR SINGLE PAD). THE GENERATOR RECOGNIZED ONLY THE SINGLE PAD AND NOT THE SPLIT PAD; THEREFORE, THE REM FEATURE OF THE GENERATOR WAS NOT FUNCTIONING CORRECTLY. THE REM ADAPTER ASSEMBLY WAS REPLACED AND THE GENERATOR FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERROR OCCURRED WITH REGARD TO THE REM FUNCTION TO THE RETURN ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379452 FORCE FX-8C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP NA

    Patients

    Seq Age Sex Outcome Treatment
    1