BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24710074 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19123
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    September 24, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FURTHER INVESTIGATED THE FAILED SOFTWARE UPDATE. THE FSE REPLACED THE ROBOT COMMON COMPUTE CONTROLLER (CCC) DUE TO THE SOFTWARE MISMATCH DURING THE 1.2 UPDATE. AFTER CCC REPLACEMENT, THE FSE WAS ABLE TO PROGRAM AND RESTORE CART FUNCTION. 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 ROBOT CCC WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED SOFTWARE MISMATCHING ISSUE WAS REPLICATED AND CONFIRMED. IN THE SYSTEM LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ROBOT CCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE FAILURE WAS TRIGGERED BY INDICATING FAULTS ON THE CCC WAS BRICK/CORRUPTED, REPLICATING THE REPORTED EVENT. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE ROOT CAUSE OF THE REPORT EVENT WAS DETERMINED TO BE A BRICKED ROBOT CCC. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    DURING AN INTERNAL SERVICE ACTIVITY, THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED A FAILED UPDATE TO 1.2 SOFTWARE. FSE INSPECTED PROGRAMMABLE NODES AND FOUND PCC-PIC APS FAILED PROGRAMMING. FSE ATTEMPTED PROGRAMING ROBOT AS A STANDALONE CART, BUT PROGRAMMING FAILED. FSE FOUND SECURITY STATUS OF PCC_PIC APPS NODE UNDEFINED AND BOARD VERSION ON BETA_1, OTHER PCC NODES SECURITY STATUS WERE PRODUCTION AND BOARD VERSION BETA_2_SECURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374196 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1