BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE HOLDER CEV700T5 DIA 5MM TUNGSTEN

    MDR report key: 3337874 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00336
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    GCJ
    PMA / PMN Number
    K080257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 3: CEV700T5 (LOT: 100901) - MANUFACTURING DATE: 09/2010. DEVICE 3 OF 3: CEV700T5 (LOT: 091001) - MANUFACTURING DATE: 10/2009. (B)(6). EVALUATION OF ALL THREE INSTRUMENTS INDICATED A BROWN RESIDUE AT THE BACK OF THE JAWS AND TWO OF THE JAWS WERE BROKEN. THE BREAKAGE WAS MOST LIKELY DUE TO IMPACT DURING THE USE OF THE REPROCESSING. THE CAUSE OF THE RESIDUE WAS NOT EVIDENT AS MULTIPLE CAUSES ARE POSSIBLE (EXTERNAL CONTAMINATION/CORROSION OF THE BREAKAGE ZONE). 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 REFERENCE #: NA. (B)(4).

    Description of Event or Problem · 1

    THREE DEVICES (CEV700T5 - QTY 3) WERE RETURNED TO MXI SERVICE AND REPAIR. "REPAIR REQUEST/INSTRUMENTS RUSTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424932 NEEDLE HOLDER CEV700T5 DIA 5MM TUNGSTEN GCJ MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV700T5 091001

    Patients

    Seq Age Sex Outcome Treatment
    1