BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE TRIAD GENERATOR

    MDR report key: 6618924 · Received June 7, 2017

    Report

    Report Number
    1717344-2017-05411
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    May 16, 2017
    Report Date
    June 14, 2017
    Manufacturer
    MITG
    Product Code
    GEI
    PMA / PMN Number
    K051644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND THE INVESTIGATION FOUND THE COMPLAINT OF REM REMAINING GREEN WAS CONFIRMED. THE INVESTIGATION FOUND THAT THE GENERATOR'S EVENT LOG SHOWED THAT THE LAST THREE ENTRIES WERE UNSUCCESSFUL REM CALIBRATION ATTEMPTS. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM CALIBRATION, BUT A ROOT CAUSE WAS NOT IDENTIFIED. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE REM FUNCTION WAS CALIBRATED TO ADDRESS THE CONDITION. NO TREND HAS BEEN IDENTIFIED. NO CORRECTIVE ACTION IS REQUIRED, BECAUSE NO TREND HAS BEEN IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE REM FUNCTION ON THE UNIT WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT, AS THE ISSUE WAS FOUND DURING TESTING. THE UNIT WAS RETURNED FOR EVALUATION AND IT WAS OBSERVED ON START-UP OF THE UNIT, THAT THE REM WAS GREEN WHEN IT SHOULD HAVE BEEN RED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400629 FORCE TRIAD GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MITG FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1