BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR INSERT CEV633-1A 350MM BOTELLA

    MDR report key: 3338227 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00266
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    October 10, 2012
    Report Date
    October 15, 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: 110301) - MANUFACTURING DATE: 03/2011. DEVICE 3 OF 3: CEV6795B (LOT: 120301) - MANUFACTURING DATE: 03/2012. (B)(6). CEV633-1A WAS EVALUATED AND THE ELECTRODE WAS NOT FUNCTIONING DUE TO A SHORT CIRCUIT. IT WAS SLIGHTLY BENT AND PRESENTED WITH SIGNS OF IMPACT ON THE COATING. THE DAMAGE IS MOST LIKELY A RESULT OF USE AT THE CLIENT'S OFFICE. CEV669B WAS EVALUATED AND FOUND TO FUNCTION AS DESIGNED. CEV6795B WAS ALSO EVALUATED AND FOUND TO FUNCTION 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 FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426112 BIPOLAR INSERT CEV633-1A 350MM BOTELLA GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON CEV633-1A 120903

    Patients

    Seq Age Sex Outcome Treatment
    1