BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COVIDIEN ES PENCIL

    MDR report key: 3330277 · Received August 28, 2013

    Report

    Report Number
    1717344-2013-00689
    Event Type
    Injury
    Date Received
    August 28, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 21, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THE INCIDENT PENCIL WILL NOT BE RETURNED TO COVIDIEN FOR EVAL. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT RECEIVED A 1CM X 1CM FULL THICKNESS BURN TO THE CORNER OF THE MOUTH DURING A TONSILLECTOMY PROCEDURE. THE PT WILL BE FOLLOWING UP WITH A PLASTIC SURGEON. A COVIDIEN PENCIL (CATALOG NUMBER UNK) WAS IN USE WITH A MEGADYNE ELECTRODE. AFTER THE INJURY OCCURRED, IT WAS NOTICED THAT THE MEGADYNE ELECTRODE WAS NOT FULLY SEATED IN THE PENCIL. THE SURGEON BELIEVES IT WAS FULLY SEATED WHEN THE PROCEDURE STARTED. THE DEVICE WAS NOT CLEANED DURING THE PROCEDURE, SO IT IS UNK HOW THE ELECTRODE BECAME UNSEATED IN THE PENCIL. A FORCE TRIAD GENERATOR WAS ALSO IN USE. THE GENERATOR WAS CHECKED BY CLINICAL ENGINEERING AND FOUND TO FUNCTION PROPERLY. NO DEVICES ARE BEING RETURNED TO COVIDIEN FOR EVAL. THE SITE IS NOT ALLEGING ANY COVIDIEN DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421660 UNKNOWN COVIDIEN ES PENCIL UNKNOWN COVIDIEN ES ACCESSORY GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other MEGADYNE ELECTRODE: CATALOG/LOT NUMBERS UNK| COVIDIEN FORCE TRIAD GENERATOR: S/N UNK