BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 5478934 · Received March 3, 2016

    Report

    Report Number
    1717344-2016-00125
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    February 10, 2016
    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). DATE OF INITIAL REPORT : (B)(6) 2016. THE UNIT HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED FORCEFX GENERATOR WAS RECEIVED FOR EVALUATION. THE INVESTIGATION OF THE UNIT FOUND THAT THE REM CONTACT QUALITY MONITORING SYSTEM WAS FUNCTIONING WELL OUT OF SPECIFICATION. SPECIFICALLY, THE REM VOLTAGE WAS FOUND TO BE LOW OUT OF SPECIFICATION AND THE TORQUE SEAL ON THE POTENTIOMETER R96 WAS BROKEN. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM VOLTAGE BUT A ROOT CAUSE WAS NOT IDENTIFIED. TO ADDRESS THIS CONDITION, THE POTENTIOMETER R96 FOR THE REM VOLTAGE WAS ADJUSTED TO SPECIFICATION. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS INDICATES THAT THIS SERIAL NUMBER WAS RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED AN ERROR CODE. HOWEVER, UPON RECEIPT OF THE UNIT FOR EVALUATION BY COVIDIEN, A PRELIMINARY INVESTIGATION FOUND THAT WHEN THE REM FUNCTION WAS TESTED, THE REM LIGHT STAYED GREEN AND ALLOWED THE UNIT TO BE ACTIVATED SIGNIFICANTLY OUTSIDE OF ACCEPTABLE LIMITS. WHEN A REM CONNECTOR WITH A CENTER POST IS CONNECTED, THE REM LIGHT WENT GREEN AND THE UNIT COULD BE ACTIVATED, AS LONG AS THE RESISTANCE ACROSS THE PINS WAS GREATER THAN 5 OHMS (ALL THE WAY TO COMPLETELY OPEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135315 FORCE FX ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1