BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    MDR report key: 3737359 · Received April 9, 2014

    Report

    Report Number
    9680837-2014-00026
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    March 18, 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. ADD'L DEVICE INFO: CEV669B, LOT#130402, BIPOLAR HANDLE, 5MM ANGLED. (B)(4). THE DEVICES WERE RETURNED FOR REPAIR. EVALUATION FOUND ONE OF THE INSTRUMENTS HAD PREVIOUSLY BEEN REPAIRED BY AN EXTERNAL COMPANY. ON BOTH INSTRUMENTS, THE ¿BLACK PLASTIC PART IS BURNT AT THE CONNECTION,¿ LIKELY THE RESULT OF ELECTRIC ARC DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED/BLOOD/TISSUE). BOTH DEVICES WERE REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BIPOLAR HANDLE INSTRUMENTS WERE RETURNED FOR SERVICE AND REPAIR. BOTH INSTRUMENTS FAILED ELECTRICAL TESTS AND THERE WAS EVIDENCE OF ELECTRICAL ARCING. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214356 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 07-06

    Patients

    Seq Age Sex Outcome Treatment
    1