BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24227086 · Received January 30, 2026

    Report

    Report Number
    2955842-2026-02848
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 5, 2026
    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
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO CORRECT THE REPORTED ERROR ON ARM 1. 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; HOWEVER THE EVALUATION IS NOT YET COMPLETE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND IN THE SYSTEM LOGS, THE ERROR 319 WAS FOUND INDICATING NODE IS NOT PRESENT AT STARTUP (NODE NAME: AXES CONTROLLER CANNULA (ACC) IN ARMNET1 USM), CONFIRMING THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A KNOWN GOOD SYSTEM WHERE THE ERROR 319 WAS TRIGGERED INDICATING NODE NOT PRESENT AT STARTUP POINTING TO THE ACC, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE CHECK ALL BOARDS FAILED FOR THE ACC. ONCE TESTING WAS COMPLETED THE ROLLING LOOP FIBER WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT REGARDING UNABLE TO MOVE ARM WAS CONFIRMED BY FAILURE ANALYSIS. THE ROOT CAUSE IS ATTRIBUTED TO A COMMUNICATION ISSUE WITH THE ROLLING LOOP FIBER IN THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 1 WAS DISABLED DUE TO ERRORS WHEN THEY WENT TO CHANGE THE INSTRUMENT OUT AND COULD NOT MOVE IT. TSE VIEWED LOGS AND FOUND 319 ON USM ARM 1, REPORTING FROM THE ACC BOARD. THE CUSTOMER REBOOTED; HOWEVER, THE ERROR PERSISTED. THE PROCEDURE WAS COMPLETING WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE USM ARM WAS RESET AND THEY CONTINUED THE PROCEDURE. THERE WERE NOT ANY ISSUES TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288894 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A 00886874110720

    Patients

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