BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORE UNIVERSAL DRIVER

    MDR report key: 4192475 · Received October 22, 2014

    Report

    Report Number
    0001811755-2014-03700
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: GRID: THE DEVICE WAS REPAIRED AND PUT BACK INTO STRYKER STOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY, THE CORE UNIVERSAL DRIVER WAS RUNNING IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671559 LOANER CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1