BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24693640 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18499
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    April 3, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    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 COMMON COMPUTE CONTROLLER (CCC) BOARD AT THE VISION SIDE CART (VSC). FSE CLEANED ALL CONNECTION FIBER POINTS TO THE VARIOUS SUB SYSTEMS FROM THE TOWER. SYSTEM WAS NOW COMMUNICATING WITH ALL SUB SYSTEMS, AND POWERS ON NORMALLY. 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 (FA). THE CCC WAS ANALYZED AND THE ERRORS 170 AND 41113 WERE FOUND SEVERAL TIME INDICATING THAT A GIVEN FEATURE MONITORED BY THE FEATURE HEALTH MONITOR IS IN INVALID STATE AND A SUPERVISOR CONSOLE CAPSULE DETECTS THE CORE IS OFFLINE, RESPECTIVELY. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS VSC CCC WAS INSTALLED, AND TESTED ON THE DV5 IN HOUSE SYSTEM WHERE PROGRAMMING WAS NOT ABLE TO PROGRAM, VSC CART TOWER WAS NOT STARTING UP IN BOTH MAINTENANCE MODE AND IN NORMAL MODE, VSC CART POWER BUTTON CONTINUE TO FLASH IN CIRCLE NONSTOP INDICATING STARTUP FAILURE, THEREFORE REPLICATING THE REPORTED EVENT. 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

    IT WAS REPORTED THAT THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT ERRORS OCCURRED ON THE SYSTEM. WHEN POWERING ON AT THE TOWER, ALL POWER BUTTONS SPIN BLUE, BUT THE SYSTEM NEVER COMPLETES SELF-TEST. LOGS SHOW POSSIBLE PROBLEM WITH CONSOLE2 SIM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539772 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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