BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1935676 · Received December 16, 2010

    Report

    Report Number
    1717344-2010-00944
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 22, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GENERATOR CONTINUED OUTPUT (LATCHED ON) AFTER THE ACTIVATION WAS RELEASED. IN THE UROLOGY ROOM THE SURGEON REPORTED THAT IN TWO CASES DURING THE DAY (A THURSDAY), THE GENERATOR LATCHED ON AFTER ACTIVATING THE DEVICE AND TRYING TO DEACTIVATE IT. IN ONE CASE, IT WAS BEING HAND ACTIVATED WITH THE HAND PIECE SWITCH AND IN THE OTHER IT WAS BEING FOOT ACTIVATED (MFR REPORT # 1717344-2010-00961). IN THE HAND SWITCH ACTIVATION, THE FOOT PEDAL WAS ALSO CONNECTED. THE GENERATOR LATCHED MULTIPLE TIMES IN EACH CASE. THE NURSE REBOOTED THE GENERATOR TO CLEAR ACTIVATION, AND USED THE SAME UNIT TO COMPLETE CASE. THE BIOMEDICAL ENGINEER SUSPECTING THE FOOT PEDAL, REPLACED THE FOOT PEDAL. THE BIOMEDICAL ENGINEER CHECKED THE FOOT PEDAL HE HAD REMOVED AND FOUND NO PROBLEM WITH IT. IN BOTH CASES ALL THE SAME EQUIPMENT WAS USED TO COMPLETE THE CASES. THERE WAS NO PT INJURY.

    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