BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24973513 · Received April 23, 2026

    Report

    Report Number
    2955842-2026-22717
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 23, 2026
    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
    TX, 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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE HELI COIL TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE HELI COIL WAS SCRAPPED AND WILL NOT BE RETURNED BACK TO ISI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE FOOT TRAY WAS NOT MOVING IN AND OUT. THE CUSTOMER STATED THAT THEY COULD HEAR THE MOTOR NOISE, BUT THERE WAS NO MOVEMENT OF THE FOOT TRAY. THE CUSTOMER WAS USING OTHER CONSOLE TO FINISH THE CASE.THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3979 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-21 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1