BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER SYS 6 RECIP

    MDR report key: 2150302 · Received June 7, 2011

    Report

    Report Number
    1811755-2011-02031
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INVESTIGATION DETAILS, THE DEVICE WAS LEAKING OIL OUT OF THE BLADE MOUNT AFTER TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING OIL DURING MAINTENANCE AT THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOANER SYS 6 RECIP KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK