BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 4161182 · Received July 23, 2014

    Report

    Report Number
    3006451981-2014-00686
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TONSILLECTOMY CASE, THE SWABS IN THE PT'S MOUTH CAUGHT FIRE. THE COVIDIEN GENERATOR WAS IN USE WITH A NON-COVIDIEN FORCEPS AND MONOPOLAR CABLE AT THE TIME. IT IS UNK IF THE PT WAS BURNED, AND IF SO, HOW THE BURN MAY HAVE BEEN TREATED. THE PT WAS DISCHARGED FROM THE FACILITY, AND NO FURTHER INFO REGARDING THIS INCIDENT IS AVAILABLE FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430099 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown COVIDIEN PEDIATRIC PLATE: MODEL E7510-25, LOT# UNK| NON-COVIDIEN FORCEPS: MODEL/LOT # UNK| NON-COVIDIEN MONOPOLAR CABLE: MODEL/LOT # UNK| COVIDIEN PEDIATRIC PLATE: MODEL E7510-25, LOT# UNK| NON-COVIDIEN MONOPOLAR CABLE: MODEL/LOT # UNK| NON-COVIDIEN FORCEPS: MODEL/LOT # UNK