BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22820766 · Received August 15, 2025

    Report

    Report Number
    2955842-2025-34517
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 25, 2025
    Report Date
    July 25, 2025
    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
    EZ
    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 FSE REPLACED THE DISTAL SETUP JOINT (SUJ) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM IN NORMAL MODE WHERE ERROR 319 INDICATING NODE NOT PRESENT WAS TRIGGERED. THE UNIT WAS ALSO INSTALLED ON A PATIENT FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED TO CONNECT 2 NODES DURING PROGRAMMING. UPON VISUAL INSPECTION, 1 SETUP JOINT LOWER BOARD (SFL) PIN WAS BENT AND PUSHED IN WHICH MIGHT HAVE CONTRIBUTE TO THE REPORTED EVENT. INSTALLED GOLDEN SFL BOARD AND IT FAILED WRIST ENCODER TEST THUS REPLICATING THE REPORTED EVENT. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE WRIST ZETTLEX ENCODER IS CONSISTENT WITH THE REPORTED PROBLEM AND IS THE POTENTIAL ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ERROR 23103 OCCURRED ON THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM3). THE CUSTOMER DISABLED THE USM3 AND CONTINUED THE CASE WITH THE REMAINING USMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE REPORTER CONFIRMED THAT THE PROBLEM OCCURRED DURING SURGERY, BEFORE THAT THE SYSTEM STARTED UP CORRECTLY. THE CUSTOMER CONTACTED FIELD SERVICE ENGINEER (FSE), AND NOT THE TECHNICAL SERVICE ENGINEER (TSE). EVEN THOUGH THEY WENT THROUGH RESTARTING THE SYSTEM, THE ONLY SOLUTION WAS TO DISABLE THE ARM.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630311 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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