BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION KIT FOR NAVSUITE

    MDR report key: 3922355 · Received July 9, 2014

    Report

    Report Number
    0001811755-2014-02425
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED ONSITE.

    Additional Manufacturer Narrative · 1

    DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED. A FOLLOW-UP WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAVIGATION KIT FOR NAVSUITE WAS LOCKING UP WHILE USING CORONAL IMAGES FOR IMPORT DURING A CRANIAL PROCEDURE. IT WAS DETERMINED THAT THE ISSUE WAS DUE TO THE FACT THAT THE CUSTOMER IMPORTED CORONAL IMAGES AS OPPOSED TO AXIAL IMAGES. THE USE OF NAVIGATION WAS ABORTED, BUT THE CASE WAS COMPLETED SUCCESSFULLY USING TRADITIONAL METHODS. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAVIGATION KIT FOR NAVSUITE WAS LOCKING UP WHILE USING CORONAL IMAGES FOR IMPORT DURING A CRANIAL PROCEDURE. IT WAS DETERMINED THAT THE ISSUE WAS DUE TO THE FACT THAT THE CUSTOMER IMPORTED CORONAL IMAGES AS OPPOSED TO AXIAL IMAGES. THE USE OF NAVIGATION WAS ABORTED, BUT THE CASE WAS COMPLETED SUCCESSFULLY USING TRADITIONAL METHODS. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400331 NAVIGATION KIT FOR NAVSUITE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1