BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLECT CRANIAL NAVIGATION SOFTWARE

    MDR report key: 2974355 · Received February 22, 2013

    Report

    Report Number
    0001811755-2013-00357
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AND EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND EVALUATED. NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED IN THE CALL SHEET THE CT WAS IMPORTED AS VIEW FROM FEET AND THE MRI SCAN WAS IMPORTED AS VIEW FROM HEAD. THE IMAGES SHOULD BE IMPORTED WITH THE SAME IMAGE ORIENTATION. THE FACT THAT THE IMAGES WERE IMPROPERLY IMPORTED LED TO THE REPORTED INACCURACY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NAVIGATION WAS INACCURATE DURING A PROCEDURE AS THE PHYSICIAN SWITCHED FROM CT IMAGE GUIDANCE TO MRI IMAGE GUIDANCE. NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED BY TRADITIONAL METHODS WITHOUT INCIDENT. UPON FOLLOW UP BY THE NAVIGATION TECHNICIAN, IT WAS NOTICED THE IMAGES HAD BEEN INCORRECTLY IMPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NAVIGATION WAS INACCURATE DURING A PROCEDURE AS THE PHYSICIAN SWITCHED FROM CT IMAGE GUIDANCE TO MRI IMAGE GUIDANCE. NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED BY TRADITIONAL METHODS WITHOUT INCIDENT. UPON FOLLOW UP BY THE NAVIGATION TECHNICIAN, IT WAS NOTICED THE IMAGES HAD BEEN INCORRECTLY IMPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78749 INTELLECT CRANIAL NAVIGATION SOFTWARE STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1