BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 2771446 · Received September 28, 2012

    Report

    Report Number
    1811755-2012-03692
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 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

    THE MOTOR, THE PC BOARD AND OTHER PARTS WERE DISCOVERED TO BE THIRD PARTY PARTS. THIS UNAUTHORIZED MODIFICATION OF THESE COMPONENTS CAN LEAD TO THE REPORTED BIAS CURRENT ERROR. THE DEVICE HAS NOT BEEN RETURNED TO THE USER FACILITY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE DEVICE CAUSED AS BIAS CURRENT ERROR TO BE DISPLAYED ON THE CONSOLE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    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