BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECULUM HOLDER FOR MCO980 LEGENT [MXI/XOM]

    MDR report key: 3306977 · Received August 26, 2013

    Report

    Report Number
    9680837-2013-00048
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 29, 2009
    Report Date
    July 29, 2009
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S
    Product Code
    JYK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE (SPECULUM HOLDER MCO981 FOR MCO980 LEGENT) INDICATED THAT ONE OF THE SPRING LEVERS HAD BROKEN OFF AT THE BASE. 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.

    Description of Event or Problem · 1

    THE DEVICE (SPECULUM HOLDER MCO981 FOR MCO980 LEGENT) WAS RETURNED TO MXI FOR SERVICE AND REPAIR. IT WAS REPORTED THAT THE SPRING DOES NOT WORK. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415709 SPECULUM HOLDER FOR MCO980 LEGENT [MXI/XOM] HOLDER, EAR SPECULUM JYK MEDTRONIC XOMED INSTRUMENTATION S.A.S MCO981 0209

    Patients

    Seq Age Sex Outcome Treatment
    1