BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK MCO205 165MM 0.3MM 90DEG

    MDR report key: 3337889 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00333
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION OF THIS INSTRUMENT INDICATED THAT THE HOOK WAS BROKEN. NO FRAGMENT WAS FOUND IN THE RETURNED BOX. NO TRACE OF PACKAGE DAMAGE (HOLE FROM HOOKS/IMPACTS) COULD BE OBSERVED. IT WAS ALSO VERY UNLIKELY THAT THE INSTRUMENT COULD HAVE BEEN REPACKAGED DAMAGED. 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

    THE DEVICE (PART#: MCO205) WAS RETURNED TO MXI SERVICE AND REPAIR. "DELIVERED INSTRUMENT NOT COMPLIANT, NO MORE HOOK, REQUEST FOR REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424934 HOOK MCO205 165MM 0.3MM 90DEG JYL MEDTRONIC XOMED INSTRUMENTATION S.A.S. MCO205 121003

    Patients

    Seq Age Sex Outcome Treatment
    1