BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB FT10

    MDR report key: 8076103 · Received November 15, 2018

    Report

    Report Number
    1717344-2018-01497
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 15, 2018
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521548350
    PMA / PMN Number
    K170170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY A VISUAL INSPECTION OF THE GENERATOR¿S EXTERIOR FOUND NO OBVIOUS ISSUES. THE GENERATOR POWERED UP WITH NO ANOMALIES NOTED. THE GENERATORS REM FUNCTION WAS TESTED IN RF OUTPUT TEST MODE, PER THE MOST CURRENT DEVICE'S SERVICE MANUAL. THE REM FUNCTION WAS TESTED THREE TIMES. THE REM FUNCTION PASSED ALL TESTING AND WAS WITHIN SPECIFICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE HAD AN OUT OF BOX FAILURE DUE TO AN INTERMITTENT RETURN ELECTRODE MONITOR(REM) FAILURE. WHEN FIRST TESTING THE UNIT AT 100 OHMS, THE REM PAD LIGHT WAS RED. WHEN THE RESISTANCE WAS CHANGED TO 50 OHMS, THE REM PAD LIGHT WAS GREEN. WHEN THE RESISTANCE WAS CHANGED TO 0 OHMS, THE REM PAD LIGHT STAYED GREEN. WHEN TRIED TO CHANGE BACK THE REM TO 50 OHMS, THE REM PAD LIGHT STAYED GREEN; AND WHEN CHANGED BACK TO 100 OHMS, THE REM PAD LIGHT TURNED RED. WHEN UNPLUGGED THE TEST LEAD FROM THE REM CONNECTOR AND PLUGGED IT BACK IN, THE REM PAD LIGHT TURNED GREEN. WHEN THE RESISTANCE WAS CHANGED TO 50 OHMS, THE REM PAD LIGHT STAYED GREEN; WHEN CHANGED TO 0 OHMS, THE PAD RETURNED RED. WHEN IT WAS CHANGED BACK TO 50, THE LIGHT TURNED GREEN; AND WHEN IT WAS CHANGED TO 100 OHMS, THE LIGHT STAYED RED. THE LIGHT ONLY EVER TURNS GREEN AT 100 OHMS IF THE TEST LEAD IS REMOVED FROM THE CONNECTOR AND THEN PLUGGED BACK IN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913622 VALLEYLAB FT10 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER VLFT10GEN 10884521548350

    Patients

    Seq Age Sex Outcome Treatment
    1