BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23891733 · Received December 25, 2025

    Report

    Report Number
    2955842-2025-49681
    Event Type
    Malfunction
    Date Received
    December 25, 2025
    Date of Event
    December 9, 2025
    Report Date
    February 11, 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
    SC, US
    Reporter Occupation
    NURSE
    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 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. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN LOGS, THE 22020 ERROR WAS FOUND INDICATING THAT DEGREE-OF-FREEDOM (DOF) 7 AND DOF 8 ARE NOT FUNCTIONING PROPERLY CAUSING THE MONOPOLAR SCISSORS AND LARGE NEEDLE DRIVER NOT TO FUNCTION IN THE FIELD. IN CONFLUENCE THE USE OF THESE TYPICAL BASIC INSTRUMENTS NOT FUNCTIONING CAUSES ERROR 22020 FAULT ENGAGEMENT FAILED TO START INDICATING THE DOF 7 AND DOF 8 MALFUNCTION. 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 USM WAS THEN INSTALLED ONTO A PATIENT FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE CARRIAGE WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMMUNICATION ERRORS PERTAINING TO THE CARRIAGE DOF 7 AND DOF 8 ASSEMBLIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WOULD NOT ACCEPT INSTRUMENTS. THE TSE CONFIRMED ERROR 22020 IN THE LOGS POINTING TO USM 3. THE CUSTOMER ELECTED NOT TO USE USM 3 TO CONTINUE WITH THE PROCEDURE. THE TSE ADVISED THE CUSTOMER TO PERFORM HARD POWER CYCLE ON THE PATIENT SIDE CART (PSC) AT THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309954 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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