BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE

    MDR report key: 2094035 · Received April 28, 2011

    Report

    Report Number
    2094035
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 28, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    ESU ELECTROSURGICAL UNIT WAS USED TO PERFORM T&A TONSILLECTOMY AND ADENOIDECTOMY. THE ESU TIP WAS RESTING ON THE SIDE OF MOUTH UNTIL NEEDED. MINOR 3RD DEGREE BURN DISCOVERED AFTER USE. TIP WAS EXAMINED BY CE CLINICAL ENGINEER AND INSULATION COATING WAS COMPROMISED; TIP ELECTRODE LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE COATED BLADE ELECTRODE GEI COVIDIEN VALLEYLAB * 200217

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR