BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIVERSAL DRIVER

    MDR report key: 3230251 · Received July 16, 2013

    Report

    Report Number
    0001811755-2013-01662
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER EVALUATION DID NOT DUPLICATE THE REPORTED UNINTENDED ACTIVATION ISSUE; HOWEVER DEBRIS AND CORROSION WERE OBSERVED DURING DEVICE DISASSEMBLY WHICH COULD CAUSE OR CONTRIBUTE TO UNINTENDED ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPS DRIVER WOULD START AND RUN ON ITS OWN DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328628 TPS UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1