BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23653855 · Received November 26, 2025

    Report

    Report Number
    2955842-2025-46428
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 3, 2025
    Report Date
    February 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DISTAL SET UP JOINT (SUJ) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN ARTEMIS, ERRORS 30 AND 32115 WERE FOUND INDICATING A WHEEL HARDWARE (HW) COMMUNICATION FAULT THROUGHOUT THE USM, AND SUJ DISTAL IN QUESTION. A COMMUNICATION LINK ERROR 40084 FROM THE SUJ DISTAL TO USM WAS ALSO FOUND, CONFIRMING THAT THE FAULTS OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND TO BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE IT TRIGGERED ERROR 26002 AND THEN 319 AFTER A RESTART WITH LOG ERRORS 30, 32115 AND 40084, THUS REPLICATING THE EVENT. THE UNIT WAS THEN TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL RELEVANT TESTS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE AXES CONTROLLER TORNADO (ACT) PRINTED CIRCUIT ASSEMBLY (PCA) IN THE DISTAL SUJ.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE DISTAL SET-UP JOINT (SUJ) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE DISTAL SUJ INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    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 SURGICAL PROCEDURE, THE ARMNET 1 OF UNIVERSAL SURGICAL MANIPULATOR (USM1) WAS FAULTING WITH SEVERAL RECOVERABLE ERRORS ON PATIENT SIDE CART (PSC). CUSTOMER STATED THAT ERRORS KEPT TRIGGERING WHILE OPERATING THE USM. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND VERIFIED SEVERAL OCCURRENCES OF RECOVERABLE FAULTS ON THE USM. TSE INFORMED CUSTOMER THAT THE ISSUE WILL BE RESOLVED BY AN ENGINEER ON SITE AND THAT THERE WAS A POSSIBILITY FOR THE ERRORS TO RE-OCCUR EVEN IF THEY WERE RECOVERED IN THE FIRST PLACE. IT WAS FURTHER ADVISED TO SEE IF THEY CAN PROCEED WITH THREE USMS IN THIS CASE. CUSTOMER ACKNOWLEDGED AND INFORMED THAT THEY CAN PROCEED AS SUGGESTED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED ISSUE OCCURRED ON USM 1. THE CASE WAS INITIALLY STARTED USING ONLY USMS 1,2 AND 3. WHEN THE FAULT OCCURRED, USM 1 WAS DISABLED AND USMS 2,3 AND 4 WERE BEING USED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT OTHER THAN A SHORT INTRAOPERATIVE DELAY. THE FAULTY COMPONENT WAS REPLACED DURING SITE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030028 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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