BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24694815 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18267
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 22, 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
    VA, 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 THE SETUP JOINT (SUJ) TO RESOLVE THE ISSUE. 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 SUJ WAS ANALYZED AND IN ARTEMIS ERROR 32100 WAS CONFIRMED INDICATING ARM FRL WAS HIT BECAUSE OF A HARDWARE IV MONITORING ERROR. UPON VISUAL INSPECTION NO ISSUES WERE FOUND WHICH WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE NO ERRORS WERE FOUND AND THE UNIT FUNCTIONED AS EXPECTED. TESTED THE DISTAL ON A PATIENT SITE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL RELEVANT TESTING. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SALPINGO-OOPHORECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN ERROR 32100 AT STARTUP AND COULD NOT RECOVER FAULT. ALL 4 UNIVERSAL SURGICAL MANIPULATOR (USM) WERE NEEDED FOR THE CASE. CUSTOMER COMPLETED MULTIPLE POWER CYCLES WITH NO CHANGE. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62067 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 00886874110720

    Patients

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