BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1924782 · Received December 10, 2010

    Report

    Report Number
    1717344-2010-00940
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT HAD A FIRST DEGREE BURN. IT WAS MINOR WITH NO TREATMENT OTHER THAN SILVADENE APPLIED. THE BURN WAS JUST BELOW THE INCISION AND WAS APPROXIMATELY ONE INCH LONG. A COVIDIEN FORCEFXC GENERATOR WAS IN USE WITH THE HAND PIECE. THE ARCING/SPARKING CAUGHT THE LAP SPONGE ON FIRE. THE FIRE WAS EXTINGUISHED IMMEDIATELY WITH NO FURTHER INJURIES.

    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