BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 2241596 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03279
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT AS REPORTED WAS CONFIRMED. THE CONTACT PINS ARE BURNT AND THE WIRES GOING TO THE FLEX STRIP HAS POOR SOLDER CONNECTIONS THE ORANGE WIRE CAME OFF WHEN WAS FLEXED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD ACTIVATE WHILE IN SAFE MODE. THIS WAS FOUND WHILE THE DEVICE WAS BEING SERVICED AT THE MFR. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO 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