BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    MDR report key: 2123349 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02074
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    November 10, 2010
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, NO FAILURES WERE NOTED. THE DEVICE WAS CLEANED, LUBED ADJUSTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP WAS SENT FOR EVAL BECAUSE, IT WAS CAUSING HAND PIECES TO RUN WITHOUT ACTIVATION. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK