BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24504226 · Received March 4, 2026

    Report

    Report Number
    2955842-2026-14938
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 3, 2026
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM). 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. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE 25520 ERROR. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS INSTALLED ONTO THE SURGEON FUNCTIONAL TEST PLATFORM (SFTP) WHERE SINE CYCLE TEST WAS FOUND TO BE FAILING ON THE MTM. ONCE TESTING WAS COMPLETED, THE GOLDEN GIMBAL WAS APPLIED BEHAVIORAL ANALYSIS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE EMBEDDED SERIALIZER MASTER YAW (ESMY) PCA, MJB PCA, EMBEDDED SERIALIZER MASTER HANDLE (ESMH) PCA WERE FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING TRAINING USING A DUAL SURGEON CONSOLE (SSC) SETUP, THAT THE SYSTEM DISPLAYED PERSISTENT ERROR FAULT 25520. INTUITIVE SURGICAL INC TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED AND REVIEW OF SYSTEM LOGS CONFIRMED THE ISSUE ON ONE OF THE SSC LEFT MASTER TOOL MANIPULATOR (MTM) ARM. USER DISABLED THE SUSPECT SSC AND CONTINUED THE TRAINING ACTIVITY WITH A SINGLE SSC SETUP. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315659 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