BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24917481 · Received April 17, 2026

    Report

    Report Number
    2955842-2026-22074
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 17, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REVIEWED THE SYSTEM LOGS WITH A TECHNICAL SUPPORT ENGINEER (TSE) AND DETERMINED THAT THE FAULT WAS LIKELY DUE TO A BLUE FIBER CONNECTION ISSUE. REVIEW OF THE SYSTEM WHEEL GIGBIT REVEALED NO ABNORMALITIES. TO ADDRESS THE REPORTED ISSUE, AN ELECTRICAL-MECHANICAL ADJUSTMENT WAS PERFORMED, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, THE LEFT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV) ON THE SURGEON SIDE CONSOLE (SSC) DISPLAYED A BLUE SCREEN, WHILE THE RIGHT EYE FUNCTIONED AS EXPECTED. THE SURGEON DETERMINED IT WAS UNSAFE TO PROCEED AND ELECTED TO CONVERT TO A LAPAROSCOPIC APPROACH. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND REVIEWED THE SYSTEM LOGS, BUT WAS UNABLE TO CONFIRM THE REPORTED ISSUE AS THE SYSTEM WAS OFFLINE AND THE CUSTOMER WAS UNABLE TO ESTABLISH AN ONSITE CONNECTION. THE TSE REQUESTED THE CUSTOMER TO CHECK THE LEFT AND RIGHT EYE VIDEO OUTPUTS ON THE VISION SIDE CART (VSC). THE CUSTOMER CONFIRMED THAT BOTH VSC VIDEO OUTPUTS WERE FUNCTIONING AS EXPECTED. THE TSE RECOMMENDED A HARD RESET OF THE SYSTEM; HOWEVER, THE CONVERSION TO LAPAROSCOPIC SURGERY OCCURRED DURING THIS TROUBLESHOOTING PROCESS. AFTER THE SYSTEM REBOOT, BOTH EYES ON THE SSC DISPLAY FUNCTIONED AS EXPECTED WITH NO ERRORS OBSERVED. IT IS UNCLEAR WHETHER ADDITIONAL PORTS WERE PLACED DURING THE PROCEDURE. THE PATIENT TOLERATED THE CHANGE IN SURGICAL APPROACH, WITH NO POSTOPERATIVE COMPLICATIONS REPORTED, AND THERE IS NO CONCERN FOR LONG-TERM COMPLICATIONS RELATED TO THIS EVENT. THE SURGEON ATTRIBUTED THE CONVERSION TO A SYSTEM FAILURE DURING STARTUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187023 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES