BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 24344702 · Received February 16, 2026

    Report

    Report Number
    1723170-2026-00246
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 21, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION ADDED TO B5. 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M 016445C001, VERSION #: 3.4. H3, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT WHEN THE SYSTEM WAS SETUP IN THE MORNING ON THE DAY OF THE CASE, THE CONNECTIONS WERE TESTED WITH IMAGE LISTENER TECHNOLOGY (ILT), RECEIVING A GREEN "CONNECTED" STATUS. THE REP DISCONNECTED ILT AND RECONNECTED WHEN SCANNING STARTED FOR THE CASE APPROXIMATELY FIVE HOURS LATER, WHERE THE GREEN CONNECTION STATUS WAS CONFIRMED. AFTER SETTING UP THE TMAP IMAGES, THE REP STARTED A NEW SESSION AND HAD THE TEAM START THE TMAP. THE NUMBERS STARTED TO UPDATE AND COUNT UP IN THE ILT STATUS BAR. THE REP HIT "CONNECT," AND THE TMAP IMAGES DID NOT TRANSFER INTO THE OPEN SESSION. THE REP TRIED TO DISCONNECT AND RECONNECT WITHOUT SUCCESS. THE TMAP WAS STOPPED, THE SESSION WAS CLOSED, AND THE REP TRIED AGAIN WITH THE SAME RESULT. ALTHOUGH THE ILT CONNECTION BAR SHOWED ACTIVE DATA, NOTHING TRANSFERRED INTO THE SESSION. THE REP VERIFIED ALL TMAP SETTINGS AND "CVS", WHICH WERE CORRECT, AND ATTEMPTED A THIRD TIME WITH NO CHANGE. THE REP COULD SEE THE TMAPS IN VISUALASE DATA TRANSFER (VDT) AND NOTICED THAT THE BASEPATH IN THE SESSION DID NOT MATCH THE LIVE TMAP SCAN. THE REP ATTEMPTED TO DISCONNECT AND USE THE ¿PREDICT NEXT¿ FUNCTION, AS IS SOMETIMES DONE WITH THIRD PARTY SYSTEMS, BUT THE ARROWS WERE GRAYED OUT. THE REP REBOOTED THE THERMAL THERAPY SYSTEM, RETRIED THE PROCESS, AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT NO UNIVERSAL SERIAL BUS (USB) WAS USED IN THE SYSTEM DURING THE CASE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT TMAP WAS NOT TRANSFERRING. DURING THE CASE THE SYSTEM WOULD NOT TRANSFER TMAP IMAGES PROPERLY INTO THE SESSION. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO RE-LOAD THE IMAGES, THE MANUFACTURER REPRESENTATIVE (REP) REBOOTED THE SYSTEM AND THE ISSUE SEEMED TO RESOLVE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466176 VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. 9735542 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female