BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 6 STERNUM

    MDR report key: 2233187 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02626
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MFR, AND A SAMPLE WAS TAKEN FOR EVAL. THE REPORTED CONDITION OF FLUID IN THE HANDPIECE WAS CONFIRMED. A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID WAS IDENTIFIED IN THE HANDPIECE WHILE THE EQUIPMENT WAS BEING TESTED. 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 SYS 6 STERNUM KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK