BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4276354 · Received November 25, 2014

    Report

    Report Number
    9680837-2014-00101
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Report Date
    November 5, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HOOK CEV225 DIA (B)(4) 5MM 450MM MONOPOLAR, LOT 110201 MANUFACTURED FEBRUARY 2011 - CEV225 - HOOK CEV225 DIA (B)(4) 5MM 450MM MONOPOLAR, LOT 140601 MANUFACTURED JUNE 2014 - CEV225 - HOOK CEV225 DIA (B)(4) 5MM 450MM MONOPOLAR, LOT UNKNOWN MANUFACTURED DATE UNKNOWN - CEV229-2A - HOOK CEV229-2A 3PK N1 FOR HOOK HANDLE, LOT UNKNOWN MANUFACTURED DATE UNKNOWN - CEV229-1A - HOOK HANDLE CEV229-1A DIA 5MM 350MM, LOT UNKNOWN. MANUFACTURED DATE UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ¿COAGULATION ISSUES¿; ¿MONOPOLAR HOOK WITH DAMAGED SHEATHS AT THE JUNCTION BETWEEN THE ISOLATED BLACK TUBE AND THE HOOK, WHICH LEAD TO COAGULATION ISSUES WITH ELECTRICAL LEAKS AND THE UNWANTED COAGULATION OF NEARBY TISSUES". THERE WERE ¿NO CONSEQUENCES¿ TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764715 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV225 140703

    Patients

    Seq Age Sex Outcome Treatment
    1