BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3150112 · Received April 17, 2013

    Report

    Report Number
    1717344-2013-00256
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 25, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA MEDWATCH: THAT DURING A TRANSANAL ENDOSCOPIC MICROSURGERY, THE PHYSICIAN WAS USING AN L HOOK DEVICE AND PENCIL BOTH CONNECTED TO THE GENERATOR WHICH HAD A FOOT PEDAL FOR ACTIVATION. WHEN THE PHYSICIAN ATTEMPTED TO USE L HOOK BY PRESSING THE FOOT PEDAL, THE PENCIL WAS ACTIVATED AND WAS NOT IN HOLDER. THE PHYSICIAN STATED HE HAD NEVER HAD THE FOOT PEDAL ACTIVATE THE PENCIL WHEN HE WAS USING THE MACHINE, IT NORMALLY ONLY ACTIVATED THE L HOOK. THE PT SUFFERED A 9MM BY 1MM BURN TO RIGHT FOURTH TOE, TREATED WITH SILVADENE OINTMENT. FURTHER INVESTIGATION SHOWED THE PROGRAMMING FOR THE MACHINE WAS CHECKED FOR THE MONOPOLAR 1 TO ACTIVATE BY THE FOOT PEDAL. CHECK WAS REMOVED FOR THE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165779 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR COVIDIEN PENCIL, LOT # UNK| COVIDIEN L HOOK, LOT # UNK