BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK HANDLE CEV229-1A DIA 5MM 350MM

    MDR report key: 3338708 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00308
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 28, 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 2: CEV229-1A (LOT: 120402) - MANUFACTURING DATE: 04/2012. (B)(6). EVALUATION OF BOTH INSTRUMENTS INDICATED THAT THE HOOK COATING WAS HEAVILY DAMAGED AND PRESENTED WITH SIGNIFICANT TRACES OF IMPACT. THE DAMAGE IS MOST LIKELY A RESULT OF IMPACT. 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 NUMBER: NA. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (PART NUMBER CEV229-1A) WERE RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424687 HOOK HANDLE CEV229-1A DIA 5MM 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON CEV229-1A 111105

    Patients

    Seq Age Sex Outcome Treatment
    1