BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24694108 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18427
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    October 21, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. FSE REPLACED PROXIMAL SET UP JOINT (SUJ). 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 PRODUCT WAS ANALYZED AND IN ARTEMIS, ERROR 319 WAS CONFIRMED INDICATING THAT THE NODES WERE NOT PRESENT AT STARTUP, STARTING AT THE AXES CONTROLLER SETUP (ACU) BOARD IN THE PROXIMAL. UPON VISUAL INSPECTION NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. INSTALLED THE PROXIMAL ONTO A GOLDEN SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED, BUT TRIGGERED ERROR 31226 IN THE LOGS, INDICATING AN AURORA ERROR (FIBER) REPORTING TO THE ACU BOARD. TESTED THE PROXIMAL ON A PFTP WHERE IT FAILED FIBER POWER TESTS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. BASED ON THESE FINDINGS, FAILURE ANALYSIS DETERMINED THAT THE ACU BOARD AND FIBER OPTIC CABLE ARE THE POTENTIAL ROOT CAUSES FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THERE WERE ERRORS ON UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 1. TSE VIEWED SYSTEM LOGS AND NOTED ERRORS 319 POINTING TO THE ACU ON ARM NET 1. THE CUSTOMER PERFORMED A HARD REBOOT; HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM (ANOTHER PATIENT SIDE CART (PSC)) WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459516 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31

    Patients

    Seq Age Sex Outcome Treatment
    1