BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 4779409 · Received May 18, 2015

    Report

    Report Number
    1717344-2015-00301
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Report Date
    April 20, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE UNIT EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : (B)(6) 2015. THE GENERATOR WAS RECEIVED AND THE INVESTIGATION FOUND THE UNIT¿S REM VOLTAGE WAS OUT OF SPEC, THE REM LIGHT WAS IN THE OFF POSITION AND ACTIVATION OF THE UNIT WAS STILL POSSIBLE. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THIS FAILURE TO BE THE BROKEN TORQUE SEAL ON THE POTENTIOMETER. THE REM CIRCUITRY WAS RECALIBRATED AND THE TORQUE SEAL REPLACED TO ADDRESS THE FAILURE. THE GENERATOR WAS CALIBRATED AND TESTING FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES WITH REM CONNECTOR. INITIAL EVALUATION OF THE INCIDENT UNIT BY COVIDIEN FOUND THAT THE REM LIGHT WENT OUT WHILE NOTHING WAS PLUGGED INTO THE REM RECEPTACLE. THIS WOULD ALLOW FOR THE UNIT TO BE ACTIVATED WITHOUT A REM PAD CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322434 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1