BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV634-1A 350MM MOUIEL

    MDR report key: 3337879 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00293
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 13, 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: CEV6795B (LOT# 120301) - MANUFACTURING DATE: MARCH 2012. THE DEVICE (PART# CEV634-1A) WAS EVALUATED AND INDICATED THAT THE ELECTRODE PALETTE WAS BROKEN IN THE MIDDLE. NO EQUIPMENT FAULT OR PRE-EXISTING CORROSION WAS OBSERVED. THE BREAKAGE WAS VERY LIKELY SUDDEN AFTER EXCESSIVE DURESS. CEV6795B WAS EVALUATED AND NO PROBLEM WAS OBSERVED ON THE TUBE. THE INSTRUMENT WAS IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS. (B)(6). 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. MEDTRONIC'S REFERENCE #: NA. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (PART# CEV634-1A AND CEV6795B) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425699 BIPOLAR INSERT CEV634-1A 350MM MOUIEL GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV634-1A 120305

    Patients

    Seq Age Sex Outcome Treatment
    1