BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8984754 · Received September 10, 2019

    Report

    Report Number
    1723170-2019-04836
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 13, 2019
    Report Date
    December 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: TROUBLESHOOTING WAS PERFORMED. THE ORIGINAL POLARIS SPECTRA SYSTEM CONTROL UNIT'S (SCU) LIGHTS FOR THE ACTIVE PORTS WERE AMBER IN COLOR. THE SCU WAS REPLACED WITH A BRAND NEW ONE, BUT THE NEW ONE HAD THE SAME ISSUE WITH THE AMBER LIGHTS AND NONFUNCTIONAL ACTIVE PORTS. TO BE SURE THAT THE REPLACEMENT SCU WAS NOT FAULTY, A WORKING SCU FROM ANOTHER SYSTEM WAS INSTALLED BUT THE ISSUE WAS STILL NOT RESOLVED (THE ACTIVE PORTS WERE FUNCTIONAL ON THE OTHER SYSTEM FROM WHICH THE SCU WAS BORROWED AND CONTINUED TO WORK ONCE IT WAS PLACED BACK IN THE SYSTEM). EVERY OTHER PART OF THE SYSTEM/SCU WAS BYPASSED BACK TO THE COMPUTER TRYING TO DIAGNOSE THE ISSUE WITH THE ACTIVE PORTS BUT THERE WAS STILL NO SUCCESS. THE NDI TOOLBOX UTILITY WAS REVIEWED WITHOUT SUCCESS IN DIAGNOSING THE ISSUE. THE ISSUE WAS NOT RESOLVED. 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

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733580, SERIAL/LOT #: (B)(4). DEVICE UDI NUMBER UNAVAILABLE. A MEDTRONIC REPRESENTATIVE (REP) PERFORMED TROUBLESHOOTING ON THE SYSTEM. THE ACTIVE REFERENCE FRAME COULD BE RECOGNIZED BY THE SYSTEM WHEN PLUGGED INTO THE REFERENCE FRAME PORT. HOWEVER, 2 TRACKERS WERE TESTED AND NEITHER OF THEM COULD BE RECOGNIZED BY THE SYSTEM (BOTH INSTRUMENTS SHOWED AN ORANGE LIGHT ON THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WHEN THE TRACKER WAS PLUGGED INTO INSTRUMENT A AND B). THE TRACKER WAS TESTED ON ANOTHER SYSTEM AND THE SYSTEM RECOGNIZED IT. AFTER THE BREAKOUT BOX AND SCU WERE REPLACED, FURTHER TROUBLESHOOTING WAS PERFORMED. THE REPLACEMENT SCU AND REPLACEMENT BREAKOUT BOX STILL SHOWED THE ISSUE WHERE THE ACTIVE PORTS DO NOT PROCESS THE INSTRUMENTS. THE CALIBRATION TRACKER SHOWED AN AMBER LIGHT ON THE SCU NO MATTER WHICH PORT WAS USED. THE REP SWAPPED AN SCU FROM A WORKING SYSTEM AND THE BEHAVIOR REMAINED THE SAME. THE BREAKOUT BOX WAS RETURNED FOR ANALYSIS. THE BREAKOUT BOX WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. GREEN STATUS WAS RETURNED FOR ALL PORTS WITH NORMAL TRACKING AND A WORKING FOOT SWITCH. THERE WAS NO PROBLEM FOUND WITH THE RETURNED BREAKOUT BOX. THE SCU WAS ALSO RETURNED FOR ANALYSIS. THE SCU WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. INSTRUMENT HAD NORMAL TRACKING WHEN CONNECTED TO ALL THREE PORTS. THERE WAS NO PROBLEM FOUND WITH THE RETURNED SCU. DEVICE MANUFACTURING DATE UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE WAS NO LONGER LOOKING TO REPAIR THE ACTIVE PORT ON THEIR NAVIGATION SYSTEM. THE SITE WOULD TEST WITH THEIR OTHER NAVIGATION SYSTEM IF THEY NEED TO USE THE ACTIVE PORT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE BREAKOUT BOX WAS DAMAGED. SPECIFICALLY, THE PORTS FOR INSTRUMENT A AND INSTRUMENT B WERE UNABLE TO BE USED. THE INSTRUMENT WAS PLUGGED INTO ANOTHER MEDTRONIC NAVIGATION SYSTEM AND IT FUNCTIONED NORMALLY. THE SITE WAS UNABLE TO GET INSTRUMENT PANEL A AND INSTRUMENT PANEL B TO WORK WITH A C-ARM TRACKER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775041 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1