BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]

    MDR report key: 3646979 · Received February 26, 2014

    Report

    Report Number
    9680837-2014-00011
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 6, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: - CEV669E: HANDLE, CEV669E DIA 5MM, CEV669E ERG BIPOLAR, LOT 100605, 510K: K99355, GEI MANUFACTURED JUNE 2010 - CEV642H: DISSECTOR INSERT, CEV642H BIPOLAR 310MM, LOT 100307 510K: K993655, GEI MANUFACTURED MARCH 2010. (B)(4). PRODUCT EVALUATION: ANALYSIS FOUND THAT THE SHEATH IS DAMAGED ON THE TUBE (CEV649-5B) AND THE ELECTRICAL INSULATION IS COMPROMISED ON ONE PART. THE MOST PROBABLE CAUSE OF THIS DAMAGING IS A SHOCK BETWEEN THE TUBE AND ANOTHER SHARP OR BLUNT INSTRUMENT DURING THE USE OR THE REPROCESSING STEPS. ANALYSIS FOUND THE HANDLE (CEV669E) IS ON SHORT CIRCUIT. NO TRACE OF BURN HAS BEEN DETECTED. THE CAUSE OF THIS SHORT CIRCUIT CANNOT BE DETERMINED WITH ABSOLUTE CERTAINTY. THE INSERT (CEV642H) IS BENT AT THE DISTAL END AND CANNOT BE ASSEMBLED WITH A TUBE. THE COATING IS SLIGHTLY DAMAGED IN THE DEFORMED AREA BUT THE ELECTRICAL INTEGRITY IS MAINTAINED. THE MOST PROBABLE CAUSE IS AN EXCESSIVE EFFORT DURING THE ASSEMBLY OR THE REPROCESSING OF THE INSERT. RESULTS: STRESS PROBLEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DOES NOT ASSEMBLE. DURING PRODUCT ANALYSIS IT WAS FOUND THAT THE TUBE (CEV649-5B) HAS COMPROMISED ELECTRICAL INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119286 TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV649-5B 130108

    Patients

    Seq Age Sex Outcome Treatment
    1