BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 2160675 · Received June 30, 2011

    Report

    Report Number
    1811755-2011-02329
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, THE DEVICE RAN IN SAFE MODE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE PC BOARD, CABLE CONNECTOR, AND DRIVE SHAFT ASSEMBLY.

    Description of Event or Problem · 1

    THE DRIVER WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION, THE DEVICE RAN IN SAFE MODE. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. 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 MICRO DRIVER ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK