BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3737360 · Received April 9, 2014

    Report

    Report Number
    9680837-2014-00027
    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. ADDITIONAL DEVICE INFO: CEV634-1A, LOT#130314, BIPOLAR INSERT 350MM; CEV634-1A, LOT#130311, BIPOLAR INSERT 350MM; CEV634-1A, LOT#120410, BIPOLAR INSERT 350MM. (B)(4). THE DEVICES WERE RETURNED FOR REPAIR. EVALUATION FOUND THREE OF THE FOUR INSTRUMENTS HAD INSULATION COATING DAMAGE AND EVIDENCE OF SHORT CIRCUIT. THE MOST PROBABLE CAUSE OF THE ELECTRICAL LEAKS IS DETERMINED TO BE NORMAL WEAR AND POTENTIAL EXCESSIVE USE RESULTING IN INSULATION COATING DAMAGE AND SUBSEQUENT BREACH OF ELECTRICAL INTEGRITY OF THE INSTRUMENTS. THE DEVICES WERE REPLACED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR BIPOLAR INSERT INSTRUMENTS WERE RETURNED FOR SERVICE AND REPAIR. THE INSTRUMENTS HAD EVIDENCE OF SHORT CIRCUIT [ELECTRICAL LEAKS]. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214895 BIPOLAR INSERT CEV634-1A 350MM MOUIEL [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 130318

    Patients

    Seq Age Sex Outcome Treatment
    1