BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR

    MDR report key: 1865038 · Received October 5, 2010

    Report

    Report Number
    1717344-2010-00681
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 8, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (B)(6). DATE OF INITIAL REPORT: (B)(6)2010. THE OPERATING TEAM REPORTED THAT, THOUGH A COVIDIEN GENERATOR WAS MENTIONED IN THE REPORT, THE GENERATOR IS NOT CONSIDERED TO BE THE FAULTY PRODUCT. THE GENERATOR WAS NOT RETURNED TO COVIDIEN SERVICE, FRANCE AND IS CURRENTLY IN USE BY THE CUSTOMER. IF THE GENERATOR 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 DAY FOLLOWING THE OPERATION, THERE WAS A BURN ON THE RIGHT THIGH OF THE PATIENT WHERE THE RETURN PATIENT ELECTRODE HAD BEEN PLACED. THE RETURN PATIENT ELECTRODE, A PRODUCT FROM CONTROL GRAPHIC (A NON-COVIDIEN PRODUCT), HAD NOT BEEN KEPT SINCE THE BURN WAS NOT NOTICED UNTIL THE NEXT DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONTROL GRAPHIC PATIENT RETURN ELECTRODE| MODEL AND LOT # UNKNOWN