BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIVERSAL DRIVER

    MDR report key: 3023021 · Received March 27, 2013

    Report

    Report Number
    0001811755-2013-00612
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION, IT WAS FOUND THAT THE HOUSING WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SERVICE AT THE MANUFACTURER THAT THE TPS UNIVERSAL DRIVER CONTINUED TO RUN WHEN THE TRIGGER WAS NO LONGER ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126666 TPS UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1