BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV634-1A 350MM MOUIEL

    MDR report key: 3338734 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00283
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2: CEV538T5, LOT# 120504 - MANUFACTURING DATE: 05/2012. (B)(6). CEV634-1A: EVAL OF CEV634-1A INDICATED THAT THE ELECTRODE PALETTES WERE DAMAGED. THE COATING WAS DAMAGED AND THE ELECTRODES WAS IN SHORT CIRCUIT. THE INSTRUMENT WAS MOST LIKELY DAMAGED AS A RESULT OF ABNORMAL USE. CEV538T5: EVAL OF CEV538T5: EVAL OF CEV538T5 INDICATED THAT THE INSTRUMENT WAS VERY HARD TO USE. THE LACK OF INSTRUMENT LUBRICATION MOST LIKELY LED TO A JAM OF THE HANDLE PIN. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (CEV634-1A AND CEV538T5) WERE RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424859 BIPOLAR INSERT CEV634-1A 350MM MOUIEL GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV634-1A 120112

    Patients

    Seq Age Sex Outcome Treatment
    1