BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL PENCIL

    MDR report key: 1820790 · Received August 26, 2010

    Report

    Report Number
    MW5017241
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 2, 2010
    Manufacturer
    VALLEYLAB OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY AND ADENOIDECTOMY, DOCTOR WAS USING THE CAUTERY WITH A NEEDLE TIP. THE TIP CAUGHT FIRE WHILE IN MOUTH OF PATIENT. CAUTERY REMOVED FROM MOUTH, DISENGAGED CAUTERY TRIGGER AND FLAME WENT AWAY. NO APPARENT BURNS OR INJURIES. DATES OF USE: (B)(6) 2010. EVENT ABATED AFTER USE OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL PENCIL CAUTERY TIP GEI VALLEYLAB OF TYCO HEALTHCARE E2515H 182092

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR