BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23639225 · Received November 24, 2025

    Report

    Report Number
    2955842-2025-46218
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE TOUCHPAD ON THE SURGEON SIDE CONSOLE (SSC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE TOUCHPAD WAS ANALYZED. ERROR 76 WAS FOUND IN SYSTEM LOGS, INDICATING THAT THE ISSUE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT COULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO AN IN-HOUSE SYSTEM AND UNDERWENT 10 POWER CYCLES, DURING WHICH ERROR 76 WAS TRIGGERED AND A BLACK SCREEN WAS DISPLAYED DURING SOME POWER CYCLES. THE FAILURE ANALYSIS TEAM WAS ALSO ABLE TO REPRODUCE THE ISSUE WHERE THE TOUCHPAD EXPERIENCED LATENCY DURING CONSOLE POWER-UP, SUCCESSFULLY REPLICATING THE COMPLAINT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT ISSUE IN THE SSC TOUCHPAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD NON-RECOVERABLE ERROR. LOGS DID INDICATE STUCK TPC ON CONSOLE. SITE CONTINUED THE PROCEDURE BY DISCONNECTING CONSOLE 1 AND CONTINUING USING ONLY CONSOLE 2. FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294134 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 DA VINCI INSTRUMENTS AND ACCESSORIES