BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 3140644 · Received May 31, 2013

    Report

    Report Number
    0001811755-2013-01266
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, WIDESPREAD CORROSION WAS DISCOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE UNIVERSAL DRIVER RAN WITHOUT THE TRIGGER BEING ACTIVATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241321 CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1