BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24691683 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18145
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 20, 2025
    Report Date
    March 25, 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
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). 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. IN ARTEMIS, THE 1162 ERROR WAS FOUND INDICATING AC MAGNETIC CANNULA SENSOR FAULT REPORTED BY THE AXES CONTROLLER SPAR (ACS) BOARD, 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 PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE AXES CONTROLLER SPAR CONNECTOR (ACSC) PRINTED CIRCUIT ASSEMBLY (PCA) AND ACSC FLAT FLEX CABLE (FFC) WAS INSPECTED AND NO FAULTS COULD BE IDENTIFIED. ALSO, THE DEGREE OF FREEDOM (DOF) 5-9 GEARBOX ASSEMBLY, ROTOR ASSEMBLY, PRELOAD SPRINGS AND SHIMS WERE REPLACED DUE TO RUST, THE RADIO FREQUENCY IDENTIFIER (RFID) POD COVER AND AXES CONTROLLER CARRIAGE INSTRUMENT (ACCI) ASSEMBLY WERE REPLACED DUE TO CONTAMINATION, THE CANNULA MOUNT ASSEMBLY WAS REPLACED DUE TO ERROR 1105 ERROR FOUND IN THE LOGS, THE CARRIAGE COVER WAS REPLACED DUE TO PUSHED IN LIGHT PIPES, THE INSERTION CLUTCH SWITCH WAS REPLACED DUE TO DAMAGED GASKET. ADDITIONALLY, THE FIBER TREND TOOL WAS PERFORMED AND PASSED. THEN, USM LINEAR BEARING AND TOP MOTOR HOUSING WERE INSPECTED AND PASSED. FINALLY, THE CARRIAGE ROTOR DOF 5 WAS REPLACED DUE TO PINCHED CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER KEPT GETTING A FAULT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND 1162 CANNULA FAULT. TSE HAD THEM TO INSTALL CANNULA AND REMOVE IT WHILE POWERED UP AND DOWN AND STILL FAULTING. THEN, TSE HAD THEM HARD POWER CYCLE THE PATIENT SIDE CART (PSC) AND FAULTED AGAIN AT POWER UP. CUSTOMER NEEDED ALL FOUR ARMS FOR THE CASE. SO THEY WON'T BE USING THE SYSTEM. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556473 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 00886874110720

    Patients

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