BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23653857 · Received November 26, 2025

    Report

    Report Number
    2955842-2025-46402
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 25, 2025
    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
    MN, US
    Reporter Occupation
    NURSE
    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 WAS ABLE TO REPRODUCE ERROR U-02 AND REPLACED THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE ERBE INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS AND THE REPORTED PROBLEM OR ERROR U-02 WAS CONFIRMED USING SYSTEM ERROR LOGS. UPON VISUAL INSPECTION THERE WAS NO ISSUE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING SYSTEM, THE UNIT ENERGIZED AND CAUTERIZED ALL PORTS AND INSTRUMENTS WITHOUT AN ISSUE. THE ERBE LOG ERROR SHOWED C-00 ERROR. UPON VISUAL INSPECTION, UNIT WAS FOUND TO HAVE SCRATCHES, SCUFFS, DENTS ON THE BEZEL AND SCRATCHES ON THE HEATSINK. CHIP IN PAINT ON THE TOP RIGHT EDGE PART OF THE COVERING/HOUSING. THE COMPLAINT WAS CONFIRMED BUT NOT REPLICATED BY FAILURE ANALYSIS. A REVIEW OF THE SITE¿S COMPLAINT HISTORY DID NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVED WITH THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SITE¿S SYSTEM LOGS WAS CONDUCTED BY A POST MARKET QUALITY ENGINEER FOR THE REPORTED PROCEDURE DATE OF (B)(6)2025 ON SYSTEM SK4419. INVESTIGATION REVEALED THE FOLLOWING ERRORS: U-02 WHICH INDICATES A SYSTEM CHECKMASTER FAILURE. DESIGN 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). WHILE THE CUSTOMER REPORTED ERROR COULD NOT BE REPLICATED DURING IN-HOUSE TESTING, A LOG REVIEW ON THE UNIT CONFIRMED ERROR U-02 OCCURRED IN THE FIELD. THE PROBABLE ROOT CAUSE OF ERROR U-02 MAY BE ATTRIBUTED TO A CHECKMASTER FAILURE ON THE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT A CAUTERY ERROR, U-02, OCCURRED FOLLOWING COMPLETION OF A CASE. TROUBLESHOOTING STARTED WITH AN ATTEMPT BY TSE TO LOCATE THE ERROR IN THE LOGS; HOWEVER, NO RELATED ENTRIES WERE FOUND. BEFORE CALLING TSE, THE CUSTOMER BROUGHT AN ALTERNATIVE VISION TOWER INTO THE ROOM TO CONTINUE AND COMPLETE THE PROCEDURE. TSE WAS NOT ABLE TO TROUBLESHOOT THE ISSUE FURTHER. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2671778 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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