BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV633-1A 350MM BOTELLA

    MDR report key: 3338203 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00267
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    October 9, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON
    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 3: CEV669B (LOT: 110306) - MANUFACTURING DATE: 03/2011. DEVICE 3 OF 3: CEV6795B (LOT: 091102) - MANUFACTURING DATE: 11/2009. (B)(6). CEV633-1A WAS EVALUATED AND THE ELECTRODE COATING WAS FOUND TO BE DAMAGED. THE ELECTRODE WAS IN SHORT CIRCUIT. THE CAUSE OF THE DAMAGE WAS MOST LIKELY A RESULT OF EXCESSIVE ABRASION DURING USE OR THE REPROCESSING STAGES. CEV669B WAS EVALUATED AND THE TUBE WAS FOUND TO BE BENT. THE RING WAS FOUND TO BE DEFORMED. CEV6795B WAS EVALUATED AND FOUND TO BE FUNCTIONING AS DESIGNED. 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 NUMBER: NA. (B)(4).

    Description of Event or Problem · 1

    THREE DEVICES (CEV633-1A, CEV669B, AND CEV6795B) WERE RETURNED TO MXI SERVICE AND REPAIR. THE CLIENT REPORTED THAT, "THE INSERT SNAGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426788 BIPOLAR INSERT CEV633-1A 350MM BOTELLA GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON CEV633-1A

    Patients

    Seq Age Sex Outcome Treatment
    1