BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2212433 · Received July 8, 2011

    Report

    Report Number
    1717344-2011-00547
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 6, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. TO DATE THE INCIDENT GENERATOR HAS NOT BEEN RECEIVED FOR EVAL. IF THE UNIT IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING AN ENT PROCEDURE, AN UNK TYPE OF HANDPIECE SPARKED AND A FLAME WAS NOTED. THERE WAS A NASAL CANNULA WITH OXYGEN IN USE AT THE TIME WHEN THE FLAME WAS NOTED. THE PT HAD BEEN PREPPED WITH AN IODINE SOLUTION AND A FACIAL TENT WAS ALSO IN USE DURING THE PROCEDURE. THE SURGICAL TEAM EXTINGUISHED THE FLAME USING A SALINE SOLUTION. 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