BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23529870 · Received November 12, 2025

    Report

    Report Number
    2955842-2025-44855
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 19, 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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND THE REPORTED FAILURE (IESU FAULTS) WAS CONFIRMED USING ARTEMIS; C-34 ERRORS LOGGED ON (B)(6) 2025 WITH INITIAL OCCURRENCE AT 9:12 AM (ARTEMIS TIME). M-11, C-37, C-30 ERRORS LIKELY RELATED. ADDITIONAL M-1F, M-32, M-B1, M-35, M-36, M-1C ERRORS LOGGED IN ARTEMIS. INSPECTION DURING FA PROCESS WAS ABLE TO REPLICATE THE REPORTED EVENT; UNIT TESTED ON SYSTEM PRESENTS C-34/C-00 ERROR ON STARTUP ((B)(6) 2025 11:04 AM US-GA). ADDITIONAL C-00, M-0B, M-11 ERRORS IN ERBE LOGS. AS A RESULT OF THESE FINDINGS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BECAUSE THE UNIT IS AN OEM PRODUCT AND CANNOT BE OPENED ON SITE FOR FURTHER ANALYSIS. ERBE WILL BE SENT TO OEM FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL DEFECT OF THE IESU.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. 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. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    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 GENERAL SURGERY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR C-34 OCCURRED ON ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) WHEN THE SURGEON WAS ACTIVATING MONOPOLAR ENERGY. THE CUSTOMER POWER CYCLED THE IESU, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER ELECTED TO USE A THIRD-PARTY GENERATOR TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592624 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-63 N/A 00886874110898

    Patients

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