BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24693573 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17871
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 4, 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
    JA
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. 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. IN ARTEMIS, THE 32056 ERROR ALONG WITH 1173 AND 1123 ERRORS, WAS FOUND INDICATING A INTER-INTEGRATED CIRCUIT (I2C) DEVICE ERROR AND A USM ENCODER ERROR ON THE AXES CONTROLLER ARM (ACA), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO AN IN-HOUSE SYSTEM WHERE THE 32056 ERROR WAS TRIGGERED WITH A 1123 ERROR IN THE LOGS, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ON AN IN-HOUSE PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE THE UNIT FAILED AGC CURRENT ON THE YAW AXIS. A GOLDEN YAW SEARCHLIGHT FLAT FLEX CABLE (FFC) WAS INSTALLED AND THE UNIT PASSED THE REQUIRED TEST, VERIFYING THE YAW SEARCHLIGHT FFC TO BE THE SOURCE OF THE FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERROR 32056 OCCURRED WHILE PREPARING FOR TOMORROW, AND IT COULD NOT BE RESOLVED BY USING THE RECOVER FAULT BUTTON OR PERFORMING A POWER CYCLE. TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED ERROR 32056 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AXES CONTROLLER ARM (ACA). THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269245 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 00886874110720

    Patients

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