BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLECT CRANIAL NAVIGATION SOFTWARE

    MDR report key: 3900242 · Received June 27, 2014

    Report

    Report Number
    0001811755-2014-02305
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K062640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF ERROR MESSAGE COULD NOT BE DUPLICATED BUT CONFIRMED ON BASIS OF THE LOG FILES. THE REPORTED EVENT OF INACCURACY AFTER THE POINTER WAS INITIALIZED CANNOT BE DUPLICATED BUT CONFIRMED AS ENOUGH INDICATIONS OF A BAD REGISTRATION WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCURACY AFTER REGISTRATION WAS OFF WHILE USING THE NAVIGATION SYSTEM II - CART FOR A CRANIOTOMY PROCEDURE. AN ERROR MESSAGE HAD APPEARED INDICATING TO UNPLUG THE SYSTEM. THE HOSPITAL STAFF CHOSE TO EXIT OUT OF THE ERROR MESSAGE INSTEAD OF UNPLUGGING THE SYSTEM. WHEN THEY CONTINUED WITH NAVIGATION AFTER THAT, THE REGISTRATION WAS INACCURATE. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE USING TRADITIONAL METHODS. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCURACY AFTER REGISTRATION WAS OFF WHILE USING THE NAVIGATION SYSTEM II - CART FOR A CRANIOTOMY PROCEDURE. AN ERROR MESSAGE HAD APPEARED INDICATING TO UNPLUG THE SYSTEM. THE HOSPITAL STAFF CHOSE TO EXIT OUT OF THE ERROR MESSAGE INSTEAD OF UNPLUGGING THE SYSTEM. WHEN THEY CONTINUED WITH NAVIGATION AFTER THAT, THE REGISTRATION WAS INACCURATE. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE USING TRADITIONAL METHODS. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCURACY AFTER REGISTRATION WAS OFF WHILE USING THE NAVIGATION SYSTEM II - CART FOR A CRANIOTOMY PROCEDURE. AN ERROR MESSAGE HAD APPEARED INDICATING TO UNPLUG THE SYSTEM. THE HOSPITAL STAFF CHOSE TO EXIT OUT OF THE ERROR MESSAGE INSTEAD OF UNPLUGGING THE SYSTEM. WHEN THEY CONTINUED WITH NAVIGATION AFTER THAT, THE REGISTRATION WAS INACCURATE. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE USING TRADITIONAL METHODS. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCURACY AFTER REGISTRATION WAS OFF WHILE USING THE NAVIGATION SYSTEM II - CART FOR A CRANIOTOMY PROCEDURE. AN ERROR MESSAGE HAD APPEARED INDICATING TO UNPLUG THE SYSTEM. THE HOSPITAL STAFF CHOSE TO EXIT OUT OF THE ERROR MESSAGE INSTEAD OF UNPLUGGING THE SYSTEM. WHEN THEY CONTINUED WITH NAVIGATION AFTER THAT, THE REGISTRATION WAS INACCURATE. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE USING TRADITIONAL METHODS. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378167 INTELLECT CRANIAL NAVIGATION SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO VERSION 1.1-14

    Patients

    Seq Age Sex Outcome Treatment
    1