BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23813407 · Received December 16, 2025

    Report

    Report Number
    2955842-2025-48680
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 21, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE FOOTREST PEDAL TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FOOTREST PEDAL WAS ANALYZED AND IT WAS NOT WORKING INDICATING THAT THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE PAINT ON CLUTCH PEDAL HAD FADE OUT. THE FOOTREST WAS INSTALLED ON A GOLDEN SYSTEM FOR ADDITIONAL TESTING. UPON STARTUP THE SYSTEM POWERED ON WITHOUT ANY ERROR. FOOTREST WAS TESTED AND THE BLUE RIGHT FOOT PEDAL WAS INTERMITTENTLY ENGAGING WHEN PRESSED DOWN. THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE IS ATTRIBUTED TO COMPONENT FAILURE ON THE RIGHT-SIDE BLUE PEDAL OF THE FOOTREST ASSEMBLY.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE INSPECTED THE SYSTEM AND OBSERVED THAT RIGHT BLUE FOOT PEDAL WAS NOT RESPONDING WHEN ENGAGED. FSE REPLACED THE FOOTREST PEDAL ON SURGEON SIDE CONSOLE (SSC) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FOOTREST PEDAL ASSEMBLY; HOWEVER, FAILURE ANALYSIS INVESTIGATIONS ARE UNDER PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE RIGHT BLUE FOOT PEDAL WAS NOT WORKING ON SURGEON SIDE CONSOLE (SSC). IT WAS FURTHER STATED THAT WHEN THEY PRESSED THE OTHER FOOT PEDALS, THEY WERE ABLE TO HEAR A CLICK BUT WITH RIGHT BLUE PEDAL, THEY COULD NOT HEAR ANY CLICKS. ADDITIONALLY, THE BIPOLAR ENERGY WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411602 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24 N/A 00886874110744

    Patients

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