BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22539298 · Received July 18, 2025

    Report

    Report Number
    2955842-2025-30458
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 25, 2025
    Report Date
    June 25, 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
    NH, 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. FSE INVESTIGATION CONFIRMED THE ERROR FAULT AND PERFORMED A PART REPLACEMENT ON THE SUSPECT SURGEON SIDE CONSOLE (SSC). THE SYSTEM WAS VERIFIED AND READY TO USE.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO INTERMITTENT SIGNAL DEGRADATION OR INCORRECT NODE REGISTRATION CAUSED BY A FAULTY FIBER TRANSCEIVER AND/OR CONTAMINATION ON THE FIBER PORTS OR CABLE ENDS, LEADING TO REPEATED SYSTEM ERRORS DURING INITIALIZATION. IT CAN BE RESOLVED BY REPLACING THE FIBER TRANSCEIVER AND RECEIVER CABLES AND POWER CYCLING THE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR 316 OCCURRED REPEATEDLY. THE CUSTOMER VERIFIED THAT THE BLUE FIBER CABLES WERE CONNECTED CORRECTLY AND TO PERFORM A POWER CYCLE. THE REPORTED ERROR REOCCURRED DURING POWER UP. TSE RECOMMENDED POWERING OFF AND DISCONNECTING THE SUSPECTED SURGEON SIDE CONSOLE (SSC). THE SYSTEM POWERED ON WITHOUT ERRORS. TSE DETERMINED A POSSIBLE FIBER CONNECTION ISSUE OR FIBER TRANSCEIVER ISSUE. TSE REVIEWED THE SYSTEM LOGS WHICH INDICATED AN UNEXPECTED NODE WAS CONNECTED. TSE NOTED THAT THE POSSIBILITY OF THE SIM BEING ACCIDENTLY CONNECTED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807279 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-06 N/A 00886874110744

    Patients

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