BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI XI

    MDR report key: 23135099 · Received September 24, 2025

    Report

    Report Number
    2955842-2025-38999
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    August 29, 2025
    Report Date
    November 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H2, H3, H6, AND H11 DEVICE EVALUATION: THE POWER SUPPLY WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED POWER COMPLAINT WAS NOT CONFIRMED. UPON VISUAL INSPECTION, THE FAN LOOKED DUSTY. THE POWER SUPPLY WAS TESTED AND THE SYSTEM STARTED WITHOUT ANY ERRORS. TEN POWER CYCLES WERE PERFORMED AND THE SYSTEM WORKED NORMALLY WITHOUT ANY ISSUES. THE GENERIC POWER DISTRIBUTOR (GPD) WAS ALSO RETURNED FOR FAILURE ANALYSIS. A VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE REPORTED ISSUE. THE GPD WAS INSTALLED IN A TEST SYSTEM WHERE IT FUNCTIONED AS EXPECTED. THE GENERIC CART CONTROLLER (GCC) WAS ALSO RETURNED FOR FAILURE ANALYSIS. A VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE REPORTED EVENT. THE GCC WAS INSTALLED ON TEST SYSTEM. UPON POWER ON, THE GCC WAS NOT VISIBLE ON A LAPTOP APPLICATION. THE SURGEON SIDE CONSOLE (SSC) DID NOT POWER ON, THERE WAS NO POWER OUTPUT. THERE WAS A RED LED LIGHT ON THE GCC, INDICATIVE THAT THE GCC FAILED. THE SURGEON BACK PLANE (SBP) WAS INSTALLED ONTO A TEST SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE TEST SYSTEM WAS SET TO RUN 10 POWER CYCLES AND SITTING IDLE FOR ONE HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED.

    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 WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED MULTIPLE PARTS TO RESOLVE THE ISSUE OF THE SSC GOING BLACK DURING A PROCEDURE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WENT BLACK ON BOTH THE VIEWER AND THE TOUCHPAD. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. TROUBLESHOOTING FIRST CONSISTED OF CHECKING THE SYSTEM LOGS, WHICH SHOWED THE SSC WAS NOT CONNECTED TO THE VISION SIDE CART (VSC). THE TSE INSTRUCTED THE CUSTOMER TO SHUT DOWN THE SYSTEM, CLEAN THE BLUE FIBER CABLE AT BOTH THE SSC AND VSC, AND RESTART. DESPITE THESE EFFORTS, THE SSC REMAINED DISCONNECTED ACCORDING TO THE VSC, WITH THE POWER BUTTON BLINKING BLUE AND NO DISPLAY ON THE SCREENS, THOUGH FAN NOISE REMAINED PRESENT. ATTEMPTS TO START IN STAND-ALONE MODE DID NOT RESTORE FUNCTION. THE SURGEON THEN ELECTED TO ABORT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641975 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-11 N/A

    Patients

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