BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23459622 · Received November 3, 2025

    Report

    Report Number
    2955842-2025-43160
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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 FIBER OPTIC CABLE (FOC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE FOC WAS RETURNED AND THE REPORTED ISSUE WAS NOT CONFIRMED. IN SYSTEM LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE FIBER OPTIC CABLE WAS INSTALLED INTO XI SURGEON SIDE CART SYSTEM. THE SYSTEM WAS POWERED CYCLED 10 TIMES AND IDLE FOR FIVE MINUTES WITH NO ISSUES. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE USER STEPPING ON THE FIBER CABLE CONNECTED TO THE PATIENT SIDE CART. THIS ISSUE CAN BE RESOLVED BY RESEATING OR REPLACING THE FIBER OPTIC CABLE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE THAT THE BLUE FIBER CABLE (BFC) WAS STEPPED ON AND PULLED OUT OF THE PATIENT SIDE CART (PSC). THE CALLER STATED THAT THE BFC RIPPED OUT THE BFC PORT ON THE BACK OF THE PSC. THE PROCEDURE WAS CONVERTED TO A NEW PSC. T HERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212758 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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