BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24695723 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18644
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    July 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
    FL, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. UPON INSPECTION THE SIM NODE REVERTED BACK TO THE GOLDEN IMAGE AFTER A SUDDEN LOSS OF POWER IN THE OR. FE REPROGRAMED CONSOLE TO RESOLVE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN OPERATING ROOM POWER LOSS, THE SYSTEM WAS FAULTING WITH ERROR 311 UPON POWERING ON. THE TECHNICAL SUPPORT ENGINEER INSTRUCTED THE OPERATING ROOM STAFF TO POWER DOWN THE CONSOLE, TOWER, AND ROBOT, AND TO TURN OFF THE BREAKERS FOR OVER TWO MINUTES. THE STAFF WERE ALSO ASKED TO DISCONNECT ALL BLUE FIBER CABLES. THE TOWER, CONSOLE, AND ROBOT WERE POWERED IN STANDALONE MODE, AND ONE OF THE CONSOLES POWERED WITH FAULT 311. THE OPERATING ROOM STAFF WERE THEN ASKED TO REMOVE THE FAULTING CONSOLE FROM THE ROOM. THE STAFF CYCLED THE POWER BUTTONS TO AMBER LED AND RECONNECTED THE BLUE FIBER CABLES IN A SINGLE CONSOLE CONFIGURATION. THE SYSTEM POWERED ON AND HOMED SUCCESSFULLY, INDICATING THAT THE DA VINCI SYSTEM WAS READY. THE OPERATING ROOM STAFF CONTINUED WITH SYSTEM SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446092 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1