BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24694267 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18399
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 12, 2025
    Report Date
    March 25, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 ERBE INTEGRATED ELECTROSURGICAL UNIT (INTEGRATED ELECTROSURGICAL UNIT (IESU)) DUE TO C-00 ERRORS. 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 ERBE RETURNED FOR FAILURE ANALYSIS WITH REPORTED PROBLEM WAS CONFIRMED USING THE SYSTEM ERROR LOGS SINCE INSTANCES OF NUMEROUS U-02 ERRORS WERE LOGGED. ADDITIONAL C-01 AND M-B1 ERRORS WERE ALSO FOUND IN THE LOGS. INSPECTION DURING FAILURE ANALYSIS PROCESS WAS ABLE TO REPLICATE THE REPORTED EVENT SINCE THE UNIT PRESENTS U-02 ERROR ON STARTUP. THE U-02 CONDITION PREVENTS ACCESS TO ERBE ERROR LOGS. THE ERBE WILL BE SENT TO ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED EVENT. A REVIEW OF THE SITE¿S SYSTEM LOGS WAS PERFORMED BY POST MARKET QUALITY ENGINEERING FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2025 ON SYSTEM SK4455. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED ERRORS: U-02 WHICH INDICATES A SYSTEM CHECKMASTER FAILURE. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT WAS NOT PERFORMED, AS THE PRODUCT INVOLVED IS NOT MANUFACTURED BY INTUITIVE SURGICAL, INC. (ISI).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED REPEATED U-02 ERRORS ON THE ERBE GENERATOR. THE CUSTOMER POWER CYCLED THE ERBE BUT THE ERROR PERSISTED. THE TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO CONNECT A THIRD-PARTY GENERATOR; THE CUSTOMER WAS NOT AWARE OF WHERE THE ACTIVATION CABLE WAS AND ENDED THE CALL STATING THAT THEY WERE LOCATING IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE PORTS WERE NOT PLACED ON THE PATIENT. THE CUSTOMER CONNECTED A THIRD PARTY COVIDEN GENERATOR TO THE SYSTEM TO CONTINUE THE CASE PRIOR TO THE PATIENT ENTERING THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331568 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 00886874110898

    Patients

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