BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 4101446 · Received September 19, 2014

    Report

    Report Number
    1717344-2014-00787
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 22, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND THE INVESTIGATION WAS ABLE TO CONFIRM THE CUSTOMER'S REPORTED ISSUE. THE MONOPOLAR FOOTSWITCH CONNECTOR ON THE FOOTSWITCH/AUDIO BOARD HAS THE PLASTIC INSULATING MATERIAL AROUND THE PINS MISSING. THE COMBINATION OF THE BROKEN MONOPOLAR FOOTSWITCH CONNECTOR AND THE INSERTION OF THE FOUR PIN FOOT PEDAL WITHOUT THE PIGTAIL CAUSED THE PINS TO SHORT AND ACTIVATE THE GENERATOR IN THE CUT MODE. THE INVESTIGATION FOUND THE ROOT CAUSE OF THE MONOPOLAR SELF-ACTIVATES WHEN THE FOUR PIN FOOT PEDAL CORD IS PLUGGED IN WITHOUT THE PIGTAIL TO BE USER ERROR. THE FOOTSWITCH/AUDIO BOARD WAS REPLACED TO CORRECT THE PROBLEM. THE GENERATOR WAS CALIBRATED, LIFE CYCLED AND FULLY TESTED. THE GENERATOR WAS FOUND TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GENERATOR'S MONOPOLAR SELF-ACTIVATED WHEN THE 4 PIN FOOTPEDAL CORD WAS PLUGGED IN WITHOUT THE PIGTAIL ADAPTER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582492 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1