BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 19586635 · Received June 21, 2024

    Report

    Report Number
    1723170-2024-01545
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 31, 2024
    Report Date
    August 29, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) THE PRODUCT: 9735675, LOT NUMBER: 14-233592, RETURNED TO THE MANUFACTURER FOR ANALYSIS. IN SUMMARY, NO FAULTS WERE FOUND. THE MONITOR CABLE WAS STUCK ON THE MONITOR WHEN RETURNED. BOTH SCREW HEADS WERE DAMAGED MAKING IT DIFFICULT TO REMOVE THE CABLE. AFTER FORCIBLY REMOVING THE CABLE, THE MONITOR WAS ABLE TO CONNECT TO A COMPUTER ON THE TEST BENCH FOR FUNCTIONAL TESTING. THE IMAGE ON THE MONITOR WAS NORMAL, NOT SHIFTED TO ONE SIDE. THERE WERE NO PROBLEMS FOUND. 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.

    Additional Manufacturer Narrative · 0

    H3: ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE MONITOR WAS REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: CABLE 9734775 DVI-M TO HD15-M 6FT MIN REPLCMT KIT 9735675 FUSION MONITOR. 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 WHEN PERFORMING PLANNED MAINTENANCE (PM), AND ADJUSTING THE CONTRAST AND BRIGHTNESS OF THE MONITOR, THE REPRESENTATIVE SELECTED "FACTORY DEFAULT" SETTING, EVEN THOUGH THAT FIXES THE MONITOR RESOLUTION AND COLOR, THE SCREEN WAS NOW SHIFTED TO THE RIGHT. THE SYSTEM WAS REBOOTED, AND FACTORY SETTINGS WERE RELOADED. THE DVI CABLES WERE RESEATED. THE REPRESENTATIVE CHANGED THE HORIZONTAL SETTING TO 0 AND IT MOVED THE SCREEN CLOSER TO THE LEFT BUT STILL WAS 1-2INCES AWAY FROM BEING CENTERED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069000 FUSION¿ ENT NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."