BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION STEALTH STATION S8 ENT SYSTEM

    MDR report key: 8096422 · Received November 21, 2018

    Report

    Report Number
    1723170-2018-05803
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 26, 2018
    Report Date
    February 23, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169838918
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE ISSUE COULD NOT BE REPLICATED.. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW OF THE SOFTWARE DETERMINED THAT THE DEFAULT MODEL WAS OF POOR QUALITY AND HAD TO BE EDITED BUT AUTO REFINE WAS NOT UTILIZED. THIS CAUSED POOR CONVERGENCE ON INTERNAL SURFACES. TRACE PATTERN WAS ALSO OF POOR QUALITY, LARGE AMOUNT OF POINTS OVER THE SAME AREA RATHER THAN COVERING MORE SURFACE. SOFTWARE IS BEHAVING AS DESIGNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE HAD DIFFICULTY REGISTERING ON MULTIPLE ATTEMPTS. NON-INVASIVE PATIENT TRACKER WAS PLACED ON UPPER LEFT CORNER OF THE FOREHEAD BECAUSE ANESTHESIA PLACED A MONITORING DEVICE ON ACROSS PATIENT'S FOREHEAD. ON THE 1ST ATTEMPT, THE SURGEON WANTED TO TRY BOTH METHODS OF REGISTERING, THE SURGEON STARTED WITH THE TRACER. THE PATIENT WAS TRACED ACROSS THE NOSE, FOREHEAD, AND TEMPLES. ZONE OF ACCURACY WAS POSTERIOR AND NOWHERE NEAR WHERE THE SURGEON TRACED. ON THE 2ND ATTEMPT, THE SURGEON AGAIN TRACED THE FACE AND WENT A LITTLE POSTERIOR AND THIS TIME, THE AREA OF ACCURACY WAS TOO LATERAL, OPPOSITE OF WHERE THE SURGEON FOCUSED HIS TRACING. THE SITE CALLED TECH SUPPORT AND THEY SUGGESTED ADDING POINTS AND EVEN LIGHTLY TRACING OVER THE CHEEK S TO SHIFT THE ZONE OF ACCURACY. ON THE THIRD ATTEMPT, THE SURGEON ADDED POINTS, BUT WOULD NOT CHANGE COLOR AFTER INITIATING, THEY WENT BACK TO THE TRACER AND THE INITIALIZATION WAS TAKING LONG. AT THE REQUEST OF THE RESIDENT, THE SITE TRIED A DIFFERENT SURGEON PROFILE. ON THE 4TH AND LAST ATTEMPT, WHILE USING POINT MERGE AND TRACER, THE SITE GOT A 2.1 ERROR METRIC, BUT THE SURGEON DID NOT WANT TO PROCEED WITH NAVIGATION SO IT WAS ABORTED. IT WAS LATER NOTED THAT THE FEATURE THAT ALLOWED THE SITE TO SEE THE INSTRUMENT DURING REGISTRATION WAS INITIALLY TURNED OFF. THE REP PERFORMED A SYSTEM CHECKOUT AFTER REGISTERING AND SAID THAT THE REP FAILED THE REGISTRATION, BUT HAD GOOD NUMBERS AND WAS ABLE TO PROCEED TO VERIFY AND ACCURATELY NAVIGATE. THERE WAS A 10-MINUTE DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL TROUBLESHOOTING FROM ARCHIVE ANALYSIS DONE BY THE TECHNICAL SERVICES (TS) SHOWED MULTIPLE REGISTRATIONS ON THE ARCHIVE. THE TRACE POINTS WERE COLLECTING HEAVILY UNDER THE SKIN AND THE MAJORITY OF THE TOUCH POINTS SHOWING ON THE REGISTRATIONS WERE SHOWING UP WITH YELLOW NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935060 NAVIGATION STEALTH STATION S8 ENT SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR