BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV634-1A 350MM MOUIEL

    MDR report key: 3338642 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00339
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 18, 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

    THE SECOND OF THREE DEVICES: CEV6795B (LOT#120201) - MFG DATE: FEBRUARY 2012; THIRD DEVICE OF THREE: CEV669B (LOT#02/04) - MFG DATE: FEBRUARY 2004. THE DEVICE (PART#CEV634-1A) WAS EVALUATED AND INDICATED THAT THE ELECTRODE COATING WAS HEAVILY DAMAGED. THE ELECTRODE WAS SHORT-CIRCUITING. THE BLADES WERE BLUNT FOLLOWING USE OF THE INSTRUMENT. RE-SHARPENING WAS REQUIRED. CEV6795B, AND CEV669B WERE EVALUATED AND NO PROBLEMS WERE OBSERVED. INSTRUMENT WERE COMPLIANT WITH MFG SPECS. (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 INTERNAL REFERENCE #: NA. (B)(4).

    Description of Event or Problem · 1

    THREE DEVICES (PART#CEV634-1A, CEV6795B, AND CEV669B) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425539 BIPOLAR INSERT CEV634-1A 350MM MOUIEL GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV634-1A 120309

    Patients

    Seq Age Sex Outcome Treatment
    1