BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV634-1A 350MM MOUIEL [MXI/XOM]

    MDR report key: 3680747 · Received March 14, 2014

    Report

    Report Number
    9680837-2014-00018
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 19, 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

    CONCOMITANT PRODUCTS: ID# CEV669B BIPOLAR HANDLE LOT # 05/03; ID# CEV6795B TUBE LOT # 091001; VALLEY LAB BIPOLAR CABLE ID# CP393-2 LOT # UNKNOWN. (B)(4). FOUR INSTRUMENTS WERE RETURNED FOR REPAIR. THE BIPOLAR INSERT FAILED ELECTRICAL TESTING. THERE IS NO VISIBLE DEFECT ON THE TUBE COATING. AFTER DISASSEMBLY OF THE ELECTRODES A BURN TRACE IS OBSERVABLE AT THE SAME LEVEL ON THE COATING OF BOTH WIRES; THE INSERT WAS REPLACED. THE BIPOLAR HANDLE AND TUBE WERE TESTED; NO ISSUES WERE DETECTED AND BOTH INSTRUMENTS PASSED ALL MANUFACTURING SPECIFICATIONS. THE BIPOLAR CABLE FAILED ELECTRICAL TESTING; THE CABLE WAS REPLACED. THE INSTRUMENTS WERE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS RETURNED FOR REPAIR. EVALUATION OF THE DEVICE FOUND THE INSTRUMENT FAILED ELECTRICAL PERFORMANCE TESTING WITH EVIDENCE OF A SHORT CIRCUIT ON THE BIPOLAR INSERT. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154201 BIPOLAR INSERT CEV634-1A 350MM MOUIEL [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 140109

    Patients

    Seq Age Sex Outcome Treatment
    1