BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23823201 · Received December 16, 2025

    Report

    Report Number
    2955842-2025-48692
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 16, 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
    CH
    Reporter Occupation
    003

    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 MASTER TOOL MANIPULATOR (MTM) 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 MTM WAS ANALYZED. IN ARTEMIS, THE 23027 ERROR WAS FOUND INDICATING C-BALANCE DPOTS (DIGITAL POT) ISSUES ON AXIS 3. UPON VISUAL INSPECTION NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS INSTALLED ONTO A SURGEON SIDE CONSOLE FIXTURE TEST PLATFORM (SFTP) WHERE ALL TEST PASSED. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE AXIS 3 COUNTERBALANCE DPOT IN THE MTM. WHILE FAILURE ANALYSIS CONFIRMED THE ISSUE VIA LOG REVIEW, IN-HOUSE TESTING WAS UNABLE TO REPLICATE THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A FAULT OCCURRED WITH ERROR 23027 ON THE SYSTEM. THE USER MENTIONED THAT THEY HAD ALREADY PERFORMED A HARD POWER CYCLE, BUT THE ISSUE PERSISTED. THE TSE GUIDED THE USER TO CHECK THE ERROR LOG, WHICH CONFIRMED ERROR 23027 POINTING TO THE LEFT MASTER TOOL MANIPULATOR (MTML). THE TSE SUGGESTED ANOTHER HARD POWER CYCLE, BUT THERE WAS NO CHANGE. THE USER CONVERTED TO LAPAROSCOPIC SURGERY TO CONTINUE WITH THE PROCEDURE AS PLANNED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT NO ADDITION INCISIONS WERE MADE AND THE PORT INCISION SIZE REMAINED UNCHANGED WHEN THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. THE PATIENT DID TOLERATE THE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445057 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A 00886874110744

    Patients

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