BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24437136 · Received February 24, 2026

    Report

    Report Number
    2955842-2026-08573
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE OF ERROR C-34 IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE GENERATOR.

    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 REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) HAS BEEN RETURNED DUE TO A RECURRING C-34 FAULT AND WAS EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. ADDITIONAL ERRORS¿C-00, C-30, C-06, M-11, M-18, M-36, M-32, AND M-0B¿WERE ALSO LOGGED, AND TESTING WAS ABLE TO REPLICATE THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL GENERATOR AND FA INSPECTION ENCOUNTERED AND REPLICATED A CRITICAL FAILURE MODE; ATTEMPTED SYSTEM TEST, UNIT FAILED TO PROCEED PAST BOOT SPLASH, DISPLAYS AN ERROR WINDOW WITH TEXT APPLICATION ERROR. THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED.

    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 LEFT HEMICOLECTOMY SURGICAL PROCEDURE USING AN XI SYSTEM, AN OPERATING ROOM (OR) STAFF MEMBER CALLED TO REPORT AN ISSUE WITH THE GENERATOR, STATING THAT THEY HAD RECEIVED AN ACTIVATION INTERRUPTED MESSAGE WITH CODE C-34. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THE ISSUE. THE TSE INQUIRED WHETHER THE GENERATOR WAS PLUGGED INTO ITS OWN DEDICATED OUTLET, WHICH WAS CONFIRMED, AND WHETHER A C-ARM OR ANOTHER ELECTROSURGICAL UNIT (ESU) WAS PRESENT IN THE ROOM, WHICH THERE WAS NOT. THE TSE EXPLAINED THAT THE GENERATOR WOULD NEED TO BE REPLACED. IF THE SURGEON AGREED, THE COAGULATION SETTING COULD BE CHANGED FROM SWIFT TO CLASSIC, BUT THIS WOULD ONLY HAVE A LIMITED EFFECT. THE PROCEDURE WAS COMPLETED AS PLANNED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498865 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1