BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR (SHANGHAI)

    MDR report key: 4961417 · Received August 3, 2015

    Report

    Report Number
    3006451981-2015-00163
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE UNIT HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FORCEFX GENERATOR WAS IN USE DURING A CARDIOLOGY PROCEDURE IN WHICH THE PATIENT RECEIVED A FIRST DEGREE BURN TO THE BUTTOCKS WHERE THE RETURN-ELECTRODE (PAD) HAD BEEN PLACED. THE MANUFACTURER OF THE RETURN ELECTRODE IS UNKNOWN. THE SETTINGS ON THE GENERATOR AT THE TIME WERE COAG - DESICCATED MODE - 40 WATTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505800 FORCE FX-8C GENERATOR (SHANGHAI) ELECTROSURGICAL GENERATOR GEI COVIDIEN LLC (SHANGHAI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1