BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UBE CEV649-5B DIA 5MM 350MM

    MDR report key: 3338600 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00378
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 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

    FIRST TWO DEVICES OF SIX DEVICES: CEV649-5B (LOT #120713) - MANUFACTURING DATE: 07/01/2012. SECOND TWO DEVICES OF SIX DEVICES: CEV625-1 (LOT #120717/120715) - MANUFACTURING DATE: 07/01/2012. THIRD TWO DEVICES OF SIX DEVICES: CEV1019-5B (LOT #120705/120703) - MANUFACTURING DATE: 07/01/2012. TWO CEV649-5B WERE 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. TWO CEV625-1 WERE EVALUATED AND INDICATED THAT THE RETURNED INSTRUMENTS WERE SHARPLY BENT. VERY LIKELY FOLLOWING EXCESS STRAIN DURING USE (DISASSEMBLY/ ASSEMBLY) OR REPROCESSING. TWO CEV1019-5B WERE EVALUATED AND NO PROBLEMS WERE OBSERVED. INSTRUMENT CONFORMS TO MANUFACTURING 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 INTERNAL REFERENCE # N/A. (B)(4).

    Description of Event or Problem · 1

    SIX DEVICES (TWO CEV649-5B, TWO CEV625-1, AND TWO CEV1019-5B) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427462 UBE CEV649-5B DIA 5MM 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV649-5B 120713

    Patients

    Seq Age Sex Outcome Treatment
    1