BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24708388 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18878
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    October 16, 2025
    Report Date
    March 26, 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
    IN, 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. FSE REPROGRAMMED THE DEVICE AND FUNCTIONALITY WAS RESTORED. 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 A NON-RECOVERABLE 311 FAULT OCCURRED. A REPRESENTATIVE CALLED DURING TRAINING TO REPORT NON-RECOVERABLE FAULTS, INCLUDING ERRORS 40096, 41107, AND PREVENTIVE MAINTENANCE 7734. THE SYSTEM HAD BEEN POWER CYCLED MULTIPLE TIMES, WITH AND WITHOUT CYCLING BREAKERS, BUT THE ISSUE PERSISTED. IT WAS NOTED THAT THE SYSTEM HAD BEEN FUNCTIONING WELL IN A DIFFERENT ROOM, BUT AFTER BEING MOVED, THE TOWER AND CONSOLE WERE PLUGGED INTO THE SAME OUTLET. UPON INSPECTION, THE TOWER HAD NO POWER, WHILE THE CONSOLE AND ROBOT DID. THE TECHNICAL SUPPORT ENGINEER RECOMMENDED DISCONNECTING THE ROBOT/CONSOLE FROM THE TOWER AND POWERING THE TOWER ON IN STAND-ALONE MODE. THIS WAS DONE, AND A 311 ERROR APPEARED ON THE TOWER SCREEN. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304359 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

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