BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20035633 · Received August 22, 2024

    Report

    Report Number
    1723170-2024-02298
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 21, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID 9735821 (LOT NUMBER: P901366) AND PRODUCT ID: 9735843 (LOT NUMBER: 230912). H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, THERE WAS AN OPTICAL COMMUNICATION FAILURE. A NEW ETHERNET CHAIN FOLLOWED BY THE INSTALLATION OF A NEW CAMERA WAS PERFORMED. AFTER REPLACING BOTH PARTS THE ERROR OF "LOCALIZER FAULTED" WAS RESOLVED BUT "LOCALIZER NOT CONNECTED" WAS STILL OCCURRING INTERMITTENTLY. FURTHER TROUBLESHOOTING OF EACH INDIVIDUAL CABLE WITHIN THE ETHERNET CHAIN ALONG WITH THE USE OF THE MANUFACTURER REPRESENTATIVE'S PERSONAL ETHERNET CABLE WAS USED TO BYPASS THE ETHERNET CHAIN BUT IT STILL RESULTED IN INTERMITTENT "LOCALIZER NOT CONNECTED". THE POWER OVER ETHERNET (POE) WAS DETERMINED TO NEED REPLACEMENT AT THIS POINT. CODES B01, C07, C08, AND D02 ARE APPLICABLE TO THIS SYSTEM SERVICING. H3, H6) THE PRODUCT ID 9735821 (LOT NUMBER: P901366) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED POSITIONING SENSOR UNIT (PSU) CONTAINED SCRATCHES ON THE HOUSING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO JANUARY OF 2019, INTERMITTENT ILLUMINATOR CURRENT LOW DATING BACK TO OCTOBER OF 2021, AND A BUMP DETECTED AUGUST OF 2024. AS WELL, THE UNIT FAILED AN ACCURACY TEST (AAK) AT 0.403 MILLIMETERS (MM) WITH A PASSING THRESHOLD OF 0.250MM. CODES B01, C07, C08, C02, AND D02 ARE APPLICABLE. H3, H6) PRODUCT ID: 9735843 (LOT NUMBER: 230912) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CABLE WAS FOUND TO HAVE AN OPEN AT PIN 6. AS WELL, THE SMALL ORANGE CABLE WAS ALSO FOUND TO HAVE AN OPEN AT PIN 6. THE OTHER BLACK CABLE AND THE CONNECTOR PASSED CONTINUITY TESTS, WITH NO OPENS OR SHORTS DETECTED. CODES B01, C02, AND D02 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE TROUBLESHOOTING FOR ANOTHER CASE, WHEN RECONNECTING THE CAMERA TO THE CAMERA CART MAST AND ACCESSING THE CLINICAL APPLICATION, THE SYSTEM DISPLAYED "LOCALIZER FAULTED". THERE WAS TROUBLESHOOTING PRESENT. IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WALKED THE MANUFACTURER REPRESENTATIVE (REP) THROUGH ACCESSING THE NETWORK DEVICE INTERFACE (NDI) "TOOLBOX" AND CONFIRMED THE BUMP STATUS HAD BEEN TRIGGERED ON THE CAMERA. NO OTHER FAULTS WERE DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952487 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown