BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 2771732 · Received September 26, 2012

    Report

    Report Number
    1717344-2012-00975
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 5, 2012
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: (B)(4) 2012. TO DATE THE INCIDENT GENERATOR HAS NOT BEEN REC'D FOR EVAL. IF THE UNIT IS REC'D 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 STATED THAT THE REM FUNCTION OF THE GENERATOR DOES NOT STOP THE UNIT FROM BEING USED ON STARTUP EVEN WHEN THE REM PAD IS NOT PROPERLY ATTACHED TO THE PT. THERE WAS NO PT INJURY, BUT THE SITE IS CONCERNED ABOUT THE POTENTIAL FOR INJURY OR FIRE TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK RETURN ELECTRODE, LOT# UNK