BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 1012792 · Received March 12, 2008

    Report

    Report Number
    1717344-2008-00074
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 12, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, THE ELECTROSURGICAL GENERATOR WAS RETURNED, TESTED AND FOUND TO OPERATE TO SPECIFICATION. THERE WAS A MISSING LEFT FRONT FOOT BUT THIS WOULD NOT HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT RETURN ELECTRODE WAS ALSO RETURNED AND FOUND TO BE WITHIN SPECIFICATION EXCEPT FOR AN INCREASED IMPEDANCE. THE INCREASED IMPEDANCE IS DUE TO THE DRYING OUT OF THE GEL ONCE USED AND OUT OF ITS SEALED PACKAGE. THIS CAUSED THE REM ALARM TO BE ACTIVATED WHEN USED WITH A GENERATOR DURING TESTING. THE CUSTOMER WAS PROVIDED WITH AN INFORMATION PACKET ABOUT HOW TO AVOID FIRES.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A BLEPHAROPLASTY WITH O2 IN USE AT A FLOW RATE OF 3 LITERS, THERE WAS A FLASH AT THE ES PENCIL AND A FIRE. THE PATIENT WAS BURNED AND SENT ON A MEDFLIGHT TO UW MEDICAL CENTER. FOLLOW-UP FOUND THAT THIS WAS A 2ND DEGREE BURN. THE PATIENT HAS SINCE BEEN DISCHARGED. THE OXYGEN TUBING, NASAL CANNULA, DRAPES ALL CAUGHT ON FIRE AND WERE IMMEDIATELY PULLED OFF. THE FIRE WAS DOUSED WITH WATER AND THE O2 TURNED OFF TO EXTINGUISH THE FIRE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR FORCEFXC| ELECTROSURGICAL GENERATOR| PATIENT RETURN ELECTRODE - LOT # UNK