BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8529585 · Received April 18, 2019

    Report

    Report Number
    1723170-2019-01846
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    April 12, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE REPORTED ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE ROLLINGSTONE COMPUTER (MODEL:9734477 LOT NO: 1842058) WAS RETURNED FOR ANALYSIS. ANALYSIS COULD NOT REPLICATE THE ISSUE. THE COMPUTER BOOTED NORMALLY TO THE APPLICATION SCREEN. THERE WAS NO BLUE SCREENS OR OTHER VIDEO ISSUES OBSERVE. NO UNRESPONSIVENESS WAS OBSERVED. THERE WAS NO FAILURE IDENTIFIED. THE CODES LISTED ABOVE ARE APPLICABLE FOR THE ROLLINGSTONE COMPUTER UPON FURTHER REVIEW. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE COMPUTER HAS BEEN RETURNED TO THE MANUFACTURER. HOWEVER, AT THE TIME OF FILING, THE COMPUTER IS UNDER ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPRESENTATIVE ATTEMPTED TO UNINSTALL AND RE-INSTALL THE ENT SOFTWARE BUT WHEN TRYING TO RE-INSTALL, THE REPRESENTATIVE GOT THE MESSAGE STATING THAT THERE WAS NOT ENOUGH SPACE. THE REPRESENTATIVE WENT INTO THE CRANIAL APPLICATION AND DELETED ABOUT 160 PATIENTS. THE REPRESENTATIVE ALSO WENT INTO THE SPINE APPLICATION AND FOUND AROUND 3000 IMAGES WHICH THE REPRESENTATIVE DELETED THROUGH THE FILE SYSTEM. THE REPRESENTATIVE ALSO EMPTIED THE TRASH FOLDER. AFTER A FULL SHUTDOWN DELETING ALL OF THE PATIENT EXAMS ON THE SYSTEM, THE REPRESENTATIVE WAS UNABLE TO INSTALL THE APPLICATION AND WAS RECEIVING THE SAME ERROR MESSAGE THAT THERE WAS NOT ENOUGH SPACE. AN ADDITIONAL SYSTEM CHECKOUT WAS PERFORMED AND FOUND THAT THE COMPUTER WAS REPLACED AND THE ISSUE RESOLVED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT WAS UNKNOWN IF LOGS WERE ABLE TO BE PULLED. THE COMPUTER WAS REPLACED BECAUSE OF FREEZING SOFTWARE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED WHEN ENTERING THE EAR, NOSE, THROAT (ENT) APPLICATION, A BLUE SCREEN OCCURRED AND THEN AFTER SEVERAL MINUTES, THE SURGEON PROFILE SHOWED. THE SYSTEM WAS MOVING SLOW. THE SITE WAS EVENTUALLY ABLE TO START DOWNLOADING THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319880 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR