BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2212899 · Received July 12, 2011

    Report

    Report Number
    1717344-2011-00551
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 29, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SOME GAUZE CAUGHT ON FIRE WHILE ON PT DURING SURGERY. THE CUSTOMER HAS NOT RELEASED ADDITIONAL INFO REGARDING THE INCIDENT.

    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