BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

    MDR report key: 6540442 · Received May 3, 2017

    Report

    Report Number
    1717344-2017-05284
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 4, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    PMA / PMN Number
    K110268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION THAT THE GENERATOR POWERED UP WITH ITS REM FUNCTION ACTIVE WAS VERIFIED THROUGH DUPLICATION. THE GENERATORS REM FUNCTION WAS TESTED AND WAS FOUND TO BE OUT OF SPECIFICATION. THE GENERATORS REM FUNCTION WAS CALIBRATED TO ADDRESS THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE SERVICE CENTER REPORTED THAT THE REM INDICATOR REMAINED GREEN WHEN THE UNIT WAS TURNED ON ALLOWING FOR A POSSIBLE SELF ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322035 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1