BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE HANDSW PENCIL

    MDR report key: 1080463 · Received July 21, 2008

    Report

    Report Number
    1717344-2008-00328
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 26, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE EVALUATION OF THE INCIDENT REPORTED: "FOLLOWING A TONSILLECTOMY PROCEDURE, IT WAS NOTED THAT THE POSITION OF THE MEGADYNE ELECTRODE AS IT WAS INSERTED IN THE VALLEYLAB PENCIL HAD APPROXIMATELY 0.30 CM TO 0.50 CM OF THE NON-INSULATED PORTION OF THE SHAFT EXPOSED WHERE THE ELECTRODE MATES WITH THE PENCIL. WHEN THE MEGADYNE ELECTRODE IS FULLY INSERTED AS INTENDED THERE IS NO PORTION OF UNINSULATED SHAFT EXPOSED. THE INCORRECT POSITIONING WAS NOT INTENTIONAL, AND IT IS UNCLEAR HOW IT CAME TO BE IN THAT POSITION. THIS EXPOSED CONDUCTIVE PORTION WAS IN A POSITION DURING THE PROCEDURE THAT COINCIDES WITH THE LOCATION OF THE UNINTENDED LESION THAT OCCURRED ON THE PATIENT'S MOUTH. THE LESION OCCURRED AT THE LEFT CORNER OF THE PATIENT'S MOUTH. THE SAME PENCIL AND ELECTRODE WERE USED AT THE RIGHT SIDE OF THE MOUTH PRIOR TO THE LEFT SIDE FOR THE SAME PROCEDURE WITHOUT INJURY." TO DATE, THE PENCIL AND GENERATOR HAVE NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A TONSILLECTOMY, AN ALTERNATE SITE BURN OCCURRED AT THE LEFT CORNER OF THE PATIENT'S MOUTH. THE HOSPITAL REPORT REFERRED TO IT AS A SERIOUS INJURY BUT PROVIDED NO DETAILS ON HOW THE INJURY WAS TREATED OR FINAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HANDSW PENCIL ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 138718

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other