BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM

    MDR report key: 3338711 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00303
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 27, 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: CEV10195R (LOT NUMBER 120522) - MANUFACTURING DATE: MAY 2012. DEVICE 3 OF 3: CEV625-1 (LOT NUMBER 100903) - MANUFACTURING DATE: SEPTEMBER 2010. THE DEVICE (PART NUMBER CEV649-5B) WAS EVALUATED AND INDICATED THAT THE TUBE SHEATHING WAS DAMAGED AND PRESENTS TRACES OF COLLISION. PROBABLY MULTIPLE COLLISIONS DURING USE AND THE REPROCESSING STAGES. CEV605G WAS EVALUATED AND INDICATED THAT THE RETURNED INSTRUMENT BLADES ARE BLUNT. THE BLADES ARE BLUNT AFTER USE AND NEED TO BE SHARPENED. CEV10195R WAS EVALUATED AND INDICATED THAT THE HANDLE WAS HARD TO USE AND IS SLIGHTLY JAMMED. PROBABLY DUE TO A LACK OF REGULAR LUBRICATION BY THE CLIENT. CEV625-1 WAS EVALUATED AND INDICATED THAT NO PROBLEM WAS OBSERVED. INSTRUMENT WAS IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS. PROBABLY MULTIPLE COLLISIONS DURING USE AND THE REPROCESSING STAGES. (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 NUMBER: NA. (B)(4).

    Description of Event or Problem · 1

    THREE DEVICES (PART NUMBER CEV649-5B, CEV10195R, AND CEV625-1) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424688 TUBE CEV649-5B DIA 5MM 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON CEV649-5B 120520

    Patients

    Seq Age Sex Outcome Treatment
    1