BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS CONSOLE

    MDR report key: 2160662 · Received June 30, 2011

    Report

    Report Number
    1811755-2011-02323
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K942956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WILL NOT BE RETURNED TO THE MFR FOR INVESTIGATION BASED ON THIS EVENT. A PRODUCT RETURN WAS REQUESTED. THE REPORTED CONDITION OF THE DEVICE TURNING ON BY ITSELF CANNOT BE CONFIRMED WITHOUT THE PRODUCT BEING AVAILABLE FOR EVAL. A F/U REPORT WILL BE SUBMITTED AFTER A QUALITY INVESTIGATION IS COMPLETED IF THE PRODUCT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STARTED ON ITS OWN DURING AN ARTHROSCOPY PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT A PROCEDURAL DELAY. THERE WAS NO MEDICAL INTERVENTION. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS CONSOLE HWE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK