BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23921619 · Received December 30, 2025

    Report

    Report Number
    2955842-2025-49890
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 8, 2025
    Report Date
    February 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WENT ON SITE AND REPLACED THE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE WITH THE ERROR POINTING TO THE POWER SUPPLY BOARD. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIT WAS INSTALLED ONTO A TEST SYSTEM. A PERFORMANCE TEST WAS SET TO 10 POWER CYCLES AND IDLE FOR 1 HR. AFTER TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE (POST-ANESTHESIA, PORTS PLACED), THE CUSTOMER HAD AN ERROR POINTING TO A FAULTY POWER SUPPLY BOARD PRIOR TO DOCKING. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED IF THE SECOND VISON TOWER IN HOUSE WAS AVAILABLE, BUT IT WAS IN USE. AFTER A REBOOT WITH HARD POWER RESET, THE SYSTEM CAME UP READY, BUT THE TSE EXPLAINED THE RISKS OF USING IT TO THE SURGEON. THE SURGEON DECIDED TO ABORT THE PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272852 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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