BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIVERSAL DRIVER

    MDR report key: 2200943 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02375
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO A BURNT FLEX STRIP ON THE POTTED TRIGGER ASSEMBLY. THE CAUSE OF THE FLEX STRIP DAMAGE WAS NOT CONFIRMED; HOWEVER, THIS MAY HAVE BEEN THE RESULT OF AN OVERLOADED CIRCUIT EITHER FROM A HIGH CURRENT OR A PROLONGED USE EVENT. THE OVERLOADED CIRCUIT MAY HAVE BURNED THE CIRCUIT CREATING THE REPORTED SMOKE.

    Description of Event or Problem · 1

    THE TPS UNIVERSAL DRIVER WAS SENT IN FOR ANALYSIS BECAUSE IT WAS SMOKING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS UNIVERSAL DRIVER ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK