BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649 DIA 5MM 350MM

    MDR report key: 3338733 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00286
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    October 26, 2012
    Report Date
    November 6, 2012
    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 6: CEV649-5B, (LOT# 120517) - MFG DATE: 05/2012. DEVICE 3 OF 6: CEV1019-5B, (LOT#120405) - MFG DATE: 04/2012. DEVICE 4 OF 6: CEV1019-5B, (LOT#120405) - MFG DATE: 04/2012. DEVICE 5 OF 6: CEV625-1, (LOT#201205MF1) - MFG DATE: 05/2012. DEVICE 6 OF 6: CEV611-1, (LOT#201206MF1) - MFG DATE: 06/2012. THE TWO CEV649-5B WERE EVALUATED AND INDICATED THAT THE SHEATH AND THE THREADING WERE DAMAGED. THE TUBES ARE BENT AND PRESENT BLOOD RESIDUE. THE ATTEMPT TO DISASSEMBLE W/O PUSHING ON THE RATCHET DAMAGED THE THREADING AND THE TUBE. THE SHEATH WAS VERY LIKELY DAMAGED AFTER COLLISIONS. THE TWO CEV1019-5B-LOT#120405 WERE EVALUATED AND INDICATED THAT THE HANDLES MOUNTED WITH INSERTS AND TUBES WERE JAMMED. VERY LIKELY AN ATTEMPT TO DISASSEMBLE W/O PUSHING ON THE RATCHET. THE TUBES, THREADINGS, RATCHETS AND INSERTS WERE DAMAGED. CEV625-1-LOT#201205MF1 AND CEV611-1-LOT#201206MF1 WERE EVALUATED AND INDICATED THAT THE INSERTS WERE BENT AND PRESENTED BLOOD OR TISSUE RESIDUE. THE ATTEMPT TO DISASSEMBLE W/O PUSHING ON THE RATCHET DAMAGED THE INSERT. MXI REMINDED THE CUSTOMER THAT THE INSTRUMENTS MUST BE DISASSEMBLED FOR CLEANING AND STERILIZATION. (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. (B)(4).

    Description of Event or Problem · 1

    SIX DEVICES (PART#CEV649-5B) WAS RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425474 TUBE CEV649 DIA 5MM 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV649-5B 120517

    Patients

    Seq Age Sex Outcome Treatment
    1