BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1033033 · Received April 22, 2008

    Report

    Report Number
    1717344-2008-00163
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 26, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENERATOR WAS RETURNED, EVALUATED AND FOUND TO OPERATE TO SPECIFICATION. IN THE CUSTOMER RESPONSE LETTER, THE CUSTOMER WAS URGED TO RETURN THE WOLF CORD TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    THE REPORT STATED THAT IN PREPARATION FOR A HYSTEROSCOPY PROCEDURE, A LAPAROSCOPIC HANDPIECE (NOT A COVIDIEN DEVICE) WAS PLUGGED INTO A WOLF CORD, WHICH WAS PLUGGED INTO A UNIPOLAR CORD AND THEN INTO THE FORCEFXC ON THE MONOPOLAR SIDE. IT WAS TRIGGERED A COUPLE OF TIMES AND THEN THE WOLF CORD CAUGHT FIRE DURING AN ACTIVATION. A POPPING SOUND WAS HEARD. IT CAUGHT FIRE AT THE LOWEST POINT OF THE ARC OF THE CORD AS THE CORD HAD BEEN STRETCHED OUT TOWARDS THE STERILE FIELD. THE FLAME WAS YELLOW. THERE WERE NO PREP SOLUTIONS NEAR THE FIRE AND IT WAS A FOOT FROM THE ANESTHESIA TUBING. THERE WERE NO LEAKS IN THE ANESTHESIA TUBING. IT BURNED BACK TO THE MACHINE AND WAS PUT OUT WITH FLUID AND BY SMOTHERING IT. THERE WAS NO PT INJURY SINCE THIS HAPPENED PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK WOLF CORD - PART #UNK