BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR

    MDR report key: 2961758 · Received January 17, 2013

    Report

    Report Number
    1717344-2012-01276
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE GENERATOR WAS RETURNED TO AN INTERNATIONAL COVIDIEN SVC CTR. THE UNIT WAS FULLY TESTED AND NOTHING WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE UNIT WAS FOUND TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS UNIT FOUND THAT IT WAS RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GENERATOR WAS IN USE WHEN A RED DIATHERMY LEAD THAT WAS IN USE CAUGHT ON FIRE. THE FIRE EXTINGUISHED ON ITS OWN WHEN THE SURGICAL STAFF STOPPED USING THE GENERATOR. THE LEAD THAT CAUGHT FIRE HAD NO LABEL AND APPEARED TO BE AN OLD ONE. THE SITE STATED THAT THEY DID NOT THINK THE GENERATOR WAS DEFECTIVE BUT SENT IT TO COVIDIEN-(B)(4) FOR EVALUATION TO BE SURE IT WAS FUNCTIONING PROPERLY. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27098 FORCE FX-8C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK DIATHERMY LEAD: LOT# UNK