BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 1060948 · Received June 13, 2008

    Report

    Report Number
    1717344-2008-00265
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 16, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS KNOWN THAT ESCHAR BUILD UP ON A DEVICE TIP CAN BURN. THE IFU STATES "WIPE THE ELECTRODE OFTEN WITH GAUZE OR OTHER MATERIAL". THE SITE WAS GIVEN AN ECRI BULLETIN ON THE IMPORTANCE OF KEEPING ESCHAR BUILD-UP OFF OF ES ELECTRODES TO PREVENT OR FIRES. THE SITE WAS ALSO SENT A OR FIRE PREVENTION PACKET AND HAS REQUESTED A COMPANY REPRESENTATIVE COME IN TO GIVE AN IN-SERVICE. TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. FURTHER INFORMATION AND THE SAMPLE HAVE BEEN REQUESTED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT A FLAME WAS OBSERVED ON THE TIP OF AN EDGE COATED BLADE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK