BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 5673716 · Received May 23, 2016

    Report

    Report Number
    1717344-2016-00373
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Report Date
    April 25, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED FORCEFXC GENERATOR WAS RETURNED FOR EVALUATION. THE RETURNED UNIT DID NOT MEET SPECIFICATION AS RECEIVED BY MEDTRONIC. THE INVESTIGATION FOUND THAT THE TORQUE SEAL ON POTENTIOMETER R96 ON THE PSRF BOARD HAD BEEN BROKEN, AND THE REM VOLTAGE WAS AT 1.3VDC. THE REM VOLTAGE SHOULD BE BETWEEN 1.5VPP TO 2.5VPP. POTENTIOMETER R96 WAS ADJUSTED TO 2.0VDC AND THE REM TEST WAS RERUN. THE UNIT WAS WITHIN SPECIFICATION. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM CALIBRATION, BUT A ROOT CAUSE WAS NOT IDENTIFIED. THE POTENTIOMETER R96 WAS REPLACED AS A PREVENTATIVE MEASURE. THE UNIT WAS THEN CALIBRATED AND TESTING FOUND THE GENERATOR TO FUNCTION NORMALLY.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : (B)(6) 2016. DATE OF FOLLOW-UP REPORT : (B)(6) 2016. ADDITIONAL INVESTIGATIVE DETAIL: A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS FOUND THAT THIS UNIT WAS UPGRADED AND WAS RELEASED MEETING ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED THAT THE REM WOULD NOT ALARM DURING TESTING. THE PRELIMINARY INVESTIGATION BY COVIDIEN FOUND THAT WHEN THE REM FUNCTION WAS TESTED, THE PEAK TO PEAK VOLTAGE WAS LOW AT 1.42V. FURTHER TESTING OF THE REM FUNCTION FOUND THAT THE REM WOULD NOT ALARM WHEN THE RESISTANCE WAS INCREASED FROM 120 UP TO 200 OHMS, THUS ALLOWING THE UNIT TO BE ACTIVATED OUTSIDE OF ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326474 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1