BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAUTERY PENCIL PUSHBUTTON

    MDR report key: 1821222 · Received August 26, 2010

    Report

    Report Number
    1417592-2010-00051
    Event Type
    Other
    Date Received
    August 26, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 20, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DURING A TONSILLECTOMY AND A PATIENT SUFFERED A BURN TO THE OUTER PORTION OF THE LIP. VERY FEW DETAILS WERE PROVIDED REGARDING THE INCIDENT. IT IS NOT BELIEVED THAT ANY ARC WAS SEEN. THE BURN WAS REPORTED TO BE MINOR AND NO MEDICAL INTERVENTION WAS INDICATED. THE ACCOUNT DID NOT HAVE ANY INFORMATION TO SUGGEST THAT THE PENCIL MALFUNCTIONED. THE ACCOUNT DID NOT RETURN THE ACTUAL SAMPLE. UNUSED SAMPLES FROM THE REPORTED LOT WERE RETURNED AND TESTED. IT IS NOT KNOW WHAT TIP WAS USED DURING THE PROCEDURE. RANDOMLY PICKED 5 SAMPLES FROM THE RETURNED BOXES AND THEY WERE TESTED. ALL SAMPLES WERE TESTED AT A SETTING OF 30-30. EACH SAMPLE WAS CYCLED 10 TIMES AT BOTH CUT AND COAG MODES. ALL PENCILS PERFORMED NORMALLY ON ALL CYCLES AT BOTH MODES. WE WERE UNABLE TO DUPLICATE THE ISSUE WITH THE RETURNED SAMPLES. HOWEVER, DUE TO THE REPORTED BURN, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T&A PROCEDURE, THE PATIENT SUFFERED A MINOR BURN TO THE MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY PENCIL PUSHBUTTON NONE GEI MEDLINE INDUSTRIES, INC. ESPB3000 100401163

    Patients

    Seq Age Sex Outcome Treatment
    1 Other