BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 6344423 · Received February 20, 2017

    Report

    Report Number
    1717344-2017-05023
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    January 14, 2017
    Report Date
    February 1, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT UNIT WAS RECEIVED BY MEDTRONIC FOR EVALUATION. THE CUSTOMER REPORTED CONDITION OF REM NOT ALARMING AT 150 OHMS WAS CONFIRMED. THE INVESTIGATION FOUND THAT THE REM POTENTIOMETER R96 HAD THE SEALANT REMOVED AND HAD BEEN ADJUSTED BY THE CUSTOMER WHICH CAUSED THE REM SIGNAL VOLTAGE TO BE TOO LOW. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE USER DAMAGE. THE REM POTENTIOMETER R96 WAS RE-ADJUSTED TO BRING THE VOLTAGE INTO SPEC AND A REM CALIBRATION WAS PERFORMED TO ADDRESS THE CONDITION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REM FUNCTION WAS ALARMING. MEDTRONIC SERVICE FOUND THAT THE REM WOULD NOT ALARM AT 150 OHMS, AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126239 FORCE FX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCEFXC

    Patients

    Seq Age Sex Outcome Treatment
    1