BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDSWITCH PENCIL W/ HOLSTER

    MDR report key: 971832 · Received December 20, 2007

    Report

    Report Number
    1717344-2007-00477
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    December 5, 2007
    Report Date
    December 6, 2007
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 12/20/2007. THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT NEAR THE END OF A TONSILLECTOMY, WITH 100% O2 BEING USED, THE DOCTOR CHANGED THE ELECTRODE ON THE END OF THE ES PENCIL TO A FINER NEEDLE ELECTRODE. THE ELECTRODE WAS INSERTED INTO THE NASAL CAVITY THROUGH THE NOSTRIL TO DO A TURBINATE REDUCTION AND ACTIVATED. THEY WERE USING A RED RUBBER "GUARD" TO LIMIT THE AMOUNT EXPOSED TO 1/2 CM OF ELECTRODE. WHEN ACTIVATED A "POP" SOUND WAS HEARD AND FLAMES SHOT OUT THE NOSTRILS. THIS WAS REPORTED AS A 1ST TO POSSIBLY 2ND DEGREE BURN TO INSIDE LEFT NOSTRIL, 1/2 TO 1 SQ CM AND WAS TREATED WITH SILVADINE. THE SETTINGS ON THE GENERATOR WERE 20W SPRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDSWITCH PENCIL W/ HOLSTER ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR FORCEFX-ELECTROSURGICAL GENERATOR| E1452- NEEDLE ELECTRODE- LOT # UNK