BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24286139 · Received February 7, 2026

    Report

    Report Number
    2955842-2026-03186
    Event Type
    Injury
    Date Received
    February 7, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 18, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THE FSE REPLACED THE REDUNDANT POWER TRAY ASSEMBLY (RPTA) AND AN VISION SIDE CART (VSC) AIR FILTER TO RESOLVE THE CUSTOMER REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY (RPTA) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE RPTA WAS ANALYZED AND FOUND TO HAVE AN ERROR INDICATING THAT THE FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION WAS PERFORMED AND NO ISSUE WAS FOUND RELATED TO THE REPORTED EVENT. THE RPTA WAS INSTALLED IN A KNOWN GOOD SYSTEM; THE BOARD VOLTAGE WAS CHECKED AND EVERYTHING OPERATED WITHIN RANGE AND PROGRAMMED SUCCESSFULLY. THE KNOWN GOOD SYSTEM WAS SET TO RUN TEN POWER CYCLES AND SAT IDLE FOR ONE HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, AND NO ERROR COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN ERROR POINTING TO INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD) BOARD. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY DUE TO THE ERROR. THE CUSTOMER POWER CYCLED; HOWEVER, THE ISSUE PERSISTED. TWO OTHER ADDITIONAL PORTS WERE PLACED DUE TO THE CONVERSION. THE PATIENT TOLERATED THE CHANGE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384295 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1