BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 7027314 · Received November 13, 2017

    Report

    Report Number
    MW5073273
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 18, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A COLOC CASE USING THE ESU, THE PT EXPERIENCED BLEEDING AND CONTINUED TO GET WORSE WHILE USING THE HAND HELD PENCIL. THE UNIT WAS TESTED OUTSIDE THE BODY AND WHEN THE UNIT WAS ACTIVATED USING THE BLUE BUTTON FOR COAGULATION, THE MACHINE WAS CUTTING. WHEN THE YELLOW BUTTON WAS PUSHED FOR CUT, THE PENCIL WAS CUTTING. EVERY TIME THE UNIT WAS USED FOR COAGULATION, THE MACHINE WAS CUTTING THROUGH THE TISSUE CAUSING MORE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803147 COVIDIEN VALLEYLAB ESU GEI MEDTRONIC / COVIDIEN VLFT10-FEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening