BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2121853 · Received May 6, 2011

    Report

    Report Number
    1717344-2011-00347
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 19, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT DURING MULTIPLE CASES WITH THIS GENERATOR, THE PENCIL PLUGGED INTO THIS GENERATOR HAD A CONSTANT SPARK AT THE TIP OF THE PENCIL AND A LOUD SIZZLING NOISE. ON F/U WITH THE BIOMEDICAL ENGINEER, HE CLARIFIED AND SAID IT WAS A SMALL FLAME AND NOT JUST ARCING. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK