BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 3234050 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01691
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PER VISUAL INSPECTION THE POTTED TRIGGER ASSEMBLY HAD CORRODED SOCKETS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE UNIVERSAL DRIVER CONTINUED TO RUN WHEN THE TRIGGER WAS NO LONGER ACTIVATED. NO FURTHER INFORMATION WAS AVAILABLE FROM THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE UNIVERSAL DRIVER CONTINUED TO RUN WHEN THE TRIGGER WAS NO LONGER ACTIVATED. NO FURTHER INFORMATION WAS AVAILABLE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335159 CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1