BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 2896528 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04107
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE TPS MICRO DRIVER WAS RETURNED FOR SERVICE. UPON EVAL AT THE MFR, IT WAS FOUND TO RUN IN SAFETY MODE. THERE WAS NO PT INVOLVEMENT AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    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