BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2903573 · Received January 1, 2013

    Report

    Report Number
    2903573
    Event Type
    Injury
    Date Received
    January 1, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 1, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO ACTIVATE A CAUTERY PENCIL WITHOUT ELECTRICAL DISCHARGE. THE ITEM AND MACHINE WAS CHECKED. FINALLY THE DEVICE ACTIVATED AND DISCHARGED AT END OF PENCIL, NOT AT THE TIP OF DEVICE. THE PATIENT WAS BURNED IN MOUTH AT RIGHT SIDE OF LIPS. THE BURN IS HALF-MOON SHAPE AT THE CORNER OF THE MOUTH, 4-5 MM IN LENGTH AT THE CORNER EXTENDING INTO THE ORAL MUCOSA INSIDE THE MOUTH. THE BURN WAS ALSO DESCRIBED AS 0.2 X 0.5CM WITH WHITISH BASE EXTENDING TO THE INNER MUCOSA. NO OTHER DEVICES WERE USED OTHER THAN THE CAUTERY MACHINE AND CAUTERY PENCIL. COVIDIEN "EDGE BUTTON SWITCH PENCIL" WITH ATTACHED CAUTERY TIP COMES INSIDE A TONSIL/ADENOID PACK THAT WAS USED IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58 * ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN * 1070106 REV.006
    59 REM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN REF # E7507 244535X
    60 FORCE FX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R NO OTHER THERAPIES