BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 1983250 · Received February 2, 2011

    Report

    Report Number
    1717344-2011-00062
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT ELECTROSURGICAL PENCIL WITH ITS ELECTRODE WAS DISCARDED BY THE SITE AND COULD NOT BE EVALUATED. THE GENERATOR USED WAS RETURNED AND TESTED. IT FUNCTIONED NORMALLY AND NOTHING WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS THE SITE NOTED, ESCHAR BUILD UP CAN BURN WITH A FLAME, AND THE IFU STATES "WIPE THE ELECTRODE OFTEN WITH GAUZE OR OTHER MATERIAL."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HANDPIECE STARTED SPARKING AND THE ELECTRODE TIP CAUGHT FIRE DURING PROCEDURE. THERE WAS NO PT INJURY. THE PENCIL WITH ITS ELECTRODE HAS BEEN DISCARDED. THE SITE SAID THAT THEY WERE AWARE THAT WHEN TISSUE GETS ON TIP, IT SOMETIMES CAN BURN WITH A FLAME.

    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 UNK FORCEFXC - ELECTROSURGICAL GENERATOR -SN (B)(4)