BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24478691 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14671
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 28, 2026
    Report Date
    May 19, 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
    003

    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 REPLACED THE HELICAL COUPLER AND GAS SPRINGS TO CORRECT REPORTED PROBLEM WITH THE FOOTREST LIFT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS ATTRIBUTED TO A FAULTY HELICAL COUPLER AND THE GAS SPRING CAUSING MOVEMENT ISSUES IN THE FOOT TRAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THE SITE STATED THEY WERE NOT ABLE TO ADJUST THE FOOT PEDALS ON THE SURGEON SIDE CONSOLE (SSC). SITE COULD HEAR THE MOTOR WITH NOTHING MOVING. SITE HAD CHANGED OUT SSC PRIOR TO CALLING IN TO COMPLETE THE CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV AND COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS WERE NOT PLACED ON THE PATIENT. IT WAS ABORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-14 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1