BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3975916 · Received August 4, 2014

    Report

    Report Number
    9680837-2014-00064
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 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

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: - CEV634-1A (QTY. 2) - BIPOLAR INSERT CEV634-1A MOUIEL, LOT NUMBER 140414. - CEV669B - HANDLE CEV669B DIA 5MM ANG BIPOLAR, LOT NUMBER 110606. (B)(4). PRODUCT EVALUATION: ANALYSIS ON THE BIPOLAR INSERTS (CEV634-1A QTY. 3), FOUND THAT THE INSERTS ARE IN SHORT CIRCUIT. THEY WERE NOT USED AND SO WERE NOT OF ANY DANGER FOR THE PATIENT OR THE USER. AFTER DISASSEMBLY OF THE WIRES, SOME IMPACTS ARE OBSERVABLE ON THE COATING. THIS PART IS NOT IN PATIENT CONTACT, THE RISK WOULD HAVE BEEN VERY LOW IF THE INSERTS HAVE BEEN USED. THE EXACT CAUSE CANNOT BE DETERMINED WITH ABSOLUTE CERTAINTY. HOWEVER, IT WOULD BE UNLIKELY TO HAVE SOME NEW INSERTS WITH DIFFERENT LOTS, ALL IN SHORT CIRCUIT BECAUSE OF A MANUFACTURING DEFECT. THE TESTS PERFORMED BY THE CUSTOMER MAY HAVE DETERIORATED THE COATING OF THE INSTRUMENTS, WHICH LED TO THE SHORT CIRCUITS. THE DEVICES FAILED ELECTRICAL TESTING. ANALYSIS ON THE HANDLE (CEV669B) FOUND THAT THE BLACK PLASTIC PART IS BURNT NEXT TO THE BIPOLAR CONNECTORS. THE BURN OF THE PLASTIC PART IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC, PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). THE DEVICE FAILED ELECTRICAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CHECKING ¿OUR BIPOLAR ELECTRODES WITH TESTING EQUIPMENT, SOME ELECTRICAL ARCS APPEARS BETWEEN THE TWO CONNECTORS. ¿IF WE ASSEMBLE THE ELECTRODE WITH A CEV679B TUBE AND A CEV669B HANDLE, SOME SPARKS APPEAR BETWEEN THE CONNECTORS OF THE HANDLE¿ IF WE PLUG A CABLE ON THE HANDLE, WE DO NOT SEE THE SPARKS ANYMORE BUT WE CAN HEAR A SIGNIFICANT CRACKLING¿¿¿ THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454337 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 140409

    Patients

    Seq Age Sex Outcome Treatment
    1