BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM

    MDR report key: 3338665 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00335
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 17, 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 5: CEV10195R, LOT#120521, MFG DATE: 05/2012. DEVICE 3 OF 5: CEV538T5, LOT#120504, MFG DATE: MAY 2012. DEVICE 4 OF 5: CEV625-1, LOT#120514, MFG DATE: MAY 2012. DEVICE 5 OF 5: CEV649-5B, LOT#121001, MFG DATE: OCTOBER 2012. THE DEVICE (PART#CEV649-5B-LOT#120317 AND 121001) WERE) EVALUATED AND INDICATED THAT THE INSTRUMENT SHEATHING WERE DAMAGED AND PRESENTS TRACES OF COLLISION. THE INSTRUMENTS SHEATHING WERE VERY LIKELY DAMAGED RESULTING FROM COLLISIONS AND ABRASIONS DURING USE OR 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. (B)(4). CEV10195R WAS EVALUATED AND INDICATED THAT THE PLASTIC WHEEL WAS BLOCKED AND TURNS POORLY. CEV538T5 WAS EVALUATED AND INDICATED THAT THE SCREW WAS PROBABLY TIGHTENED BY THE USERS. CEV625-1 WAS EVALUATED AND INDICATED THAT THE HANDLE WAS JAMMED AND DIFFICULT TO USE. THE JAM WAS DUE TO A LACK OF REGULAR LUBRICATION ON THE INSTRUMENT. CEV649-5B WAS EVALUATED AND NO PROBLEM WAS OBSERVED. INSTRUMENT WAS IN ACCORDANCE WITH THE MFR'S SPECS.

    Description of Event or Problem · 1

    FIVE DEVICES (PART#CEV649-5B (QTY2), CEV10195R, CEV538T5, AND CEV625-1) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427490 TUBE CEV649-5B DIA 5MM 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV649-5B 120317

    Patients

    Seq Age Sex Outcome Treatment
    1