BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER SYSTEM 6 ST ROTARY

    MDR report key: 2472751 · Received February 23, 2012

    Report

    Report Number
    1811755-2012-00648
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOANER HANDPIECE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING AN OIL-LIKE SUBSTANCE FROM THE END OF THE DEVICE WHILE THE EQUIPMENT WAS BEING CLEANED. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOANER SYSTEM 6 ST ROTARY KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK