BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22172453 · Received June 9, 2025

    Report

    Report Number
    2955842-2025-23428
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 14, 2025
    Report Date
    May 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 TWO REMOTE ARM CONTROLLER (RAC) BOARDS TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. BOTH RAC BOARDS WERE RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERROR WAS CONFIRMED AND NOT REPLICATED. IN LOGS, THE ERROR 252/281/307 WAS FOUND INDICATING THE FAULT, CONFIRMING THE FAULT OCCURRED IN THE FIELD. VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE UNITS WERE INSTALLED ONTO A GOLDEN SYSTEM WHERE WAS TRIGGERED INDICATING FAULT ON THE RAC. THEN THE GOLDEN SYSTEM WAS SET TO RUN 10 MINUTES SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 3 DAYS. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED, BUT NO ERROR COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SITE CONTACTED TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT ERRORS 281 AND 252. TSE HAD SITE DO EMERGENCY POWER OFF (EPO) AND BREAKER RESET, AND THE SITE WAS ABLE TO CONTINUE IN THE CASE. FURTHERMORE, IT WAS NOTICED THAT THE LOGS HAD A SECOND 281 ERROR AND THEN THE SYSTEM UNDOCKED, AND POWER CYCLED. IT WAS STATED THAT THE SYSTEM FAULTED 15 MINUTES LATER INTO THE SURGERY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318785 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-13 N/A 00886874110744

    Patients

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