BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23251954 · Received October 9, 2025

    Report

    Report Number
    2955842-2025-41118
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 18, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS ATTRIBUTED TO A FAULTY ROLLING LOOP FIBER CAUSING COMMUNICATION FAILURES WITHIN THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND THE DETECTION OF THE AXES CONTROLLER, CARRIAGE (ACC) NODE. THIS ISSUE CAN BE RESOLVED BY REPLACING THE UNIT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS REQUESTED THE USM TO BE RETURNED FOR FAILURE ANALYSIS TESTING. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND THE REPORTED 319 ERROR WAS CONFIRMED AND REPLICATED. IN LOGS, THE 319 ERROR WAS FOUND INDICATING NODE NOT PRESENT ON THE USM ACC PCA, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE ROLLING LOOP FIBER WAS FOUND TANGLED AROUND BALLS CREW THAT WOULD BE RELATED TO THE REPORT EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 319 ERROR WAS TRIGGERED INDICATING FAULT ON THE PCC3, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PFTP WHERE THE ROLLING LOOP FIBER WAS FOUND TO BE FAILING ON THE INSERTION AXIS. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE ROLLING LOOP FIBER WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL DEFECT OF THE USM.

    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 UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE SYSTEM HAD A NON-RECOVERABLE FAULT AND THEY REBOOTED THE SYSTEM EXPERIENCED A RECOVERABLE FAULT. TSE VIEWED LOGS AND NOTED RECOVERABLE FAULT #319 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. TSE HAD SITE PERFORM HARD REBOOT WITH NO CHANGE. THE SITE DISABLED USM 2 AND CONTINUED WITH 3 USMS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583558 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-38 N/A

    Patients

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