BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24720351 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19633
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 18, 2025
    Report Date
    March 27, 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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE OUTER DISTAL SET UP JOINT (SUJ) AND UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE REPORTED ISSUE. ISI RECEIVED THE DA VINCI PRODUCTS TO PERFORM FAILURE ANALYSIS. THE OUTER DISTAL SUJ WAS ANALYZED, AND DURING REVIEW OF THE SYSTEM LOGS, ERROR 26002 WAS NOT FOUND, BUT ERRORS 319 AND 307 WERE IDENTIFIED INDICATING A NODE NOT PRESENT THROUGHOUT THE USM, SUJ DISTAL AND PROXIMAL. IT WAS ALSO COUPLED WITH WHEEL COMMUNICATION ERROR 32115 AND MOTOR AXIS MESSAGE ERROR 25730, THUS CONFIRMING THAT THE FAULTS OCCURRED IN THE FIELD. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM WHERE IT PERFORMED WITHIN SPECIFICATION. THE UNIT WAS THEN TESTED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE THE WRIST BRAKE FAILED TO RELEASE AND HAD LOG ERRORS 32115 ON NODES A AND B. FAILURE ANALYSIS INSTALLED GOLDEN AXES CONTROLLER TORNADO (ACT) AND IT FAILED NODE CHECK B AND C, THUS REPLICATING THE REPORTED EVENT. A GOLDEN SETUP FRU LOWER (SFL) WAS INSTALLED, ABA TESTED, AND VERIFIED IT TO BE THE SOURCE OF THE FAULT WITH LOG ERRORS 32058 AND 48100. UPON VISUAL INSPECTION, 2 SFL PINS WERE FOUND TO BE SLIGHTLY PUSHED DOWN. THE USM WAS ANALYZED AND THE REPORTED 319 ERROR WAS CONFIRMED BUT NOT REPLICATED. IN THE SYSTEM, THE 319 ERROR WAS FOUND INDICATING NODE IS NOT PRESENT AT STARTUP, NODE NAME: ACT TO AXES CONTROLLER CARRIAGE (ACC), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE UNIT WAS THEN INSTALLED ONTO A PFTP WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. THE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE OF THE SFL PRINTED CIRCUIT ASSEMBLY (PCA). THE PROBABLE ROOT CAUSE IS ALSO ATTRIBUTED TO COMPONENT FAILURE OF THE FIELD REPLACEABLE UNITS (FRU) CONNECTOR POGO-PIN PCA OF THE USM. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS DISABLED AFTER AN ERROR 26002. THE ERROR 26002 RETURNED IMMEDIATELY AFTER A RESTART. AS A RESULT, THE CLINICAL SALES REPRESENTATIVE (CSR) DISABLED USM 4 TO RESUME THE SYSTEM USE. THE CSR PROVIDED THE POP-UP LOGS TO THE TECHNICAL SUPPORT ENGINEER (TSE), BUT THE ERROR 26002 MENTIONED WAS NOT IN THE LOGS. THE TSE IDENTIFIED ERROR 23098 POINTING TO INCONSTANCY BETWEEN THE VALUE READ AND THE ONE MEASURED. THE BRAKE INVOLVED WAS THE ONE LOCATED AT DEGREES OF FREEDOM (DOF) 3 ON USM 4 PATH. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69353 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-57 N/A 00886874110720

    Patients

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