BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED PENCIL

    MDR report key: 441936 · Received February 5, 2003

    Report

    Report Number
    441936
    Event Type
    Other
    Date Received
    February 5, 2003
    Date of Event
    January 3, 2003
    Report Date
    January 14, 2003
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGERY DONE UNDER LOCAL ANESTHESIA, EXCISION OF LIPOMA, RIGHT POSTERIOR SCALP. BACK OF HEAD SHAVED AND PREPPED WITH DURA PREP. WHEN FINISHING UP THE ELECTROCAUTERY, THERE WAS A LITTLE BIT OF FLASH IGNITION OF THE OXYGEN THAT THE PT HAD BEEN RECEIVING WITHIN THE OPERATIVE AREA PER NASAL CANNULA WHICH WAS QUICKLY EXTINGUISHED BY STOPPING USING THE BOVIE AND COMPRESSING THE AREA WITH A TOWEL. PT RECEIVED TWO DIME SIZED BLISTERED AREAS ON BACK OF NECK. POLYSPORIN AND DRESSING APPLIED TO AREA. PENCIL AND PAD NOT SAVED. POSSIBLE LOT NUMBERS ESU PENCIL (021004-1 OR 021011-1) AND ESU GROUND PAD (0209301 OR 0211192 OR 0211262).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED PENCIL ESU PENCIL GEI CONMED ELECTROSURGERY CONMED PENCIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other VALLEYLAB FORCE FX, CONMED PENCIL REF #130307,| CONMED PAD REF #410-2000.