BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 1030215 · Received April 14, 2008

    Report

    Report Number
    1717344-2008-00152
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 18, 2008
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT : 04/14/2008. THE SAMPLE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A C-SECTION A SMALL FLAME WAS OBSERVED AT THE TIP OF THE PENCIL. IT SCORCHED SOME FAT AT THE TIP AS THEY WERE CUTTING, BUT THERE WAS NO INJURY TO THE PATIENT. ANOTHER PENCIL WAS OPENED AND USED WITHOUT ANY FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTONSWITCH PENCIL ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP, (VALLEYLAB) 120498

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR PATIENT RETURN ELECTRODE - LOT # 131633