BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23688222 · Received December 1, 2025

    Report

    Report Number
    2955842-2025-47066
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 20, 2025
    Report Date
    December 1, 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
    VA, 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 REPLACED THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO ADDRESS THE M-02 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 WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED PROBLEM OF M-02 ERRORS WAS CONFIRMED SINCE THE SYSTEM ERROR LOGS REPORTED M-02 ERRORS AND ADDITIONAL RELATED ERRORS (C-82, C-83, C-71, M-11, 1-71, 2-71, 3-71, 1-88, 1-87). INSPECTION DURING FA REPLICATED THE REPORTED EVENT; UNIT PRESENTED M-02-3/M-02 ON STARTUP DURING SYSTEM TESTING. ERBE LOGS ALSO SHOW FURTHER M-02, M-0B, AND C-00 ENTRIES. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED A CPU OR SENSOR MODULE TIMEOUT, OR A COMMUNICATION TIMEOUT THROWING M-02 AND C-38.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT DURING SETUP TO REPORT THAT THEY KEPT RECEIVING AN ACTIVATION INTERRUPTED ERROR ON THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND VERIFIED M-02 ERRORS IN THE LOGS. THE TSE WALKED THE CUSTOMER THROUGH AN ERBE HARD POWER CYCLE, HOWEVER, THE ERROR PRESENTED AGAIN ON POWER UP. AS A RESULT, THE CUSTOMER ELECTED TO MOVE TO A FORCE TRIAD GENERATOR UNIT AND REQUESTED FOLLOW UP FROM THE FIELD SERVICE ENGINEER (FSE). THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE ISSUE. PATIENT DEMOGRAPHICS ASSOCIATED WITH THE EVENT WERE ADDITIONALLY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764644 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES