BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23206744 · Received October 3, 2025

    Report

    Report Number
    2955842-2025-40201
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 22, 2025
    Report Date
    September 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE COULD NOT REPLICATE THE REPORTED ISSUE AND CONTACTED A TSE WHO ADVISED THE MULTIPLE NON-RELATED ERRORS COULD BE RELATED TO THE BLUE FIBER CABLES NOT BEING FULLY SEATED. THE FSE REPLACED A FIBER OPTIC CABLE AT THE PATIENT SIDE CART (PSC) AND RAN TESTS WITH NO ISSUES. THE SYSTEM WAS VERIFIED AND READY FOR USE. THE REPLACED COMPONENT WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL CHOLECYSTECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. REPRESENTATIVE REPORTED TO THE TECHNICAL SERVICE ENGINEER (TSE) THAT THE CUSTOMER EXPERIENCED A RECOVERABLE FAULT AND POWER CYCLED THE SYSTEM AND THEN OBSERVED A NON-RECOVERABLE FAULT. THE TSE THEN WALKED THE CUSTOMER THOUGH A HARD POWER CYCLE OF SYSTEM WITH NO CHANGE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC. IT WAS NOT CONVERTED TO ANOTHER DA VINCI SYSTEM, AS NO ADDITIONAL SYSTEM WAS AVAILABLE AT THE TIME. NO ADDITIONAL PORTS WERE PLACED, AND PORT INCISIONS WERE NOT INCREASED. THE PATIENT TOLERATED THE CONVERSION, AND THERE WAS NO INJURY REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FSE NEVER AT ANY POINT REPLICATED THE FAULT THE CUSTOMER EXPERIENCED. THE FSE CONFIRMED THEY ONLY REPLACED THE ORANGE FIBER CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318236 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A

    Patients

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