BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1751190 · Received June 29, 2010

    Report

    Report Number
    1717344-2010-00442
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 23, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: COVIDIEN LP (VALLEYLAB). (B) (4). THE GENERATOR WAS CHECKED OUT BY THE SITE AND FOUND TO BE OPERATING OK. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL INFO FROM U/F REPORT: (B) (4). COVIDIEN BOVIE. BOVIE. COVIDIEN, (B) (4).

    Description of Event or Problem · 1

    THE MEDWATCH STATES: THE PT, WHILE UNDERGOING SURGERY FOR A MITRAL VALVE REPAIR, EXPERIENCED A BURN TO THE RIGHT HIP. IT APPEARS THAT THE TOWEL CLAMP CAME IN CONTACT WITH THE CABLE OF THE ESU HAND PIECE. THE CONTACT CREATED A SHORT IN THE TWO WIRES CONTAINED WITHIN THE CABLE WHICH TURNED ON THE COAG AND ROUTED ELECTRICAL CURRENT THRU THE TOWEL CLAMP AND ULTIMATELY INTO THE PT CAUSING A BURN TO THE PT'S RIGHT HIP. FOLLOW-UP INFO: THE CUSTOMER REPORTED THAT THIS WAS A 9CM BY 5CM FULL THICKNESS BURN. FOLLOW-UP SURGERY WAS REQUIRED TO EXCISE TISSUE TO ADDRESS BURN.

    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 79 YR Other