BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 21735374 · Received March 31, 2025

    Report

    Report Number
    1723170-2025-01507
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 23, 2025
    Report Date
    March 31, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169838918
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735859. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 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 DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WOULD NOT LOAD IMAGES FROM PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS), SAYING THAT "QUERYING THE NETWORK FAILED" AND THAT THE "IMAGES WERE UNAVAILABLE." USER TRIED THREE DIFFERENT ETHERNET CABLES AND FOUR DIFFERENT WALL PORTS WITHOUT SUCCESS. TROUBLESHOOTING INCLUDED TESTING THE DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) TRANSFER PACS, AND YELLOW, WHILE PACS PORT WAS RED. IT WAS SUGGESTED TO LOAD IMAGES ONTO THE SYSTEM BY DOWNLOADING THE IMAGES FROM PACS ONTO A USB OR CD. THE SITE FORMATTED THEIR 64GB USB TO EXFAT AND TRIED TO LOAD THE IMAGES THAT WAY. THEY DID NOT HAVE A CD/DVD BURNER AVAILABLE. NO RESOLUTION WAS REACHED AND THE SURGEON DECIDED TO ABORT THE CASE. THEY HAD BEEN DOWN FOR OVER AN HOUR. NO INCISION HAD BEEN MADE TO THE PATIENT, BUT THE PATIENT WAS ASLEEP DURING THE TIME OF THE CALL. THE SURGERY, NAVIGATION, AND IMAGING WERE ALL ABORTED. THERE WAS A DELAY OF 1 HOUR OR LONGER. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833121 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female "SEE H11...."