BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV64-5B DIA 5MM 350MM

    MDR report key: 3338643 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00338
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 14, 2013
    Report Date
    December 18, 2013
    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 3: CEV10195D: LOT#120105, MFG DATE: JANUARY 2012. DEVICE 3 OF 3: CEV625-1: LOT#120301, MFG DATE: MARCH 2012. THE DEVICE (PART#CEV649-5B) WAS EVALUATED AND INDICATED THAT THE INSTRUMENT SHEATH WAS DAMAGED AND SHOWED SIGNS OF IMPACT. THE INSTRUMENT SHEATH WAS MOST LIKELY DAMAGED BY SHOCK OR ABRASION DURING USE OR REPROCESSING CEB10195D WAS EVALUATED AND INDICATED THAT THE INSTRUMENT RACK WAS SLIGHTLY JAMMED. LACK OF LUBRICATION. CEV625-1 WAS EVALUATED AND NO PROBLEMS WERE OBSERVED. INSTRUMENT WAS COMPLIANT WITH MFG SPECS. NO GRIP DEFECTS OBSERVED. 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

    THREE DEVICES (PART # CEV649-5B, CEV10195D, AND CEV625-1) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424892 TUBE CEV64-5B DIA 5MM 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV649-5B 120304

    Patients

    Seq Age Sex Outcome Treatment
    1