BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21459231 · Received February 25, 2025

    Report

    Report Number
    2955842-2025-02177
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 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
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RETURNED FOR FAILURE ANALYSIS AND THE ERROR 319 WAS CONFIRMED AND REPLICATED. SYSTEM LOGS FOUND ERROR 319 INDICATING A NODE NOT PRESENT AT START UP ON NODE ACC, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE ROLLING LOOP FIBER WAS MISALIGNED AND NOT ALLOWING CARRIAGE TO MOVE PROPERLY ON INSERTION. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR 319 WAS TRIGGERED INDICATING FAULT ON THE AXES CONTROLLER, CARRIAGE (ACC), REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE CHECK BOARDS PRESENT TEST FAILED WAS FOUND TO BE FAILING ON THE ACC. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE ROLLING LOOP FIBER, AN ELECTRICAL COMPONENT FAILURE.

    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 (USM3). SYSTEM INSPECTED, TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE USM FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PROSTATECTOMY - RADICAL W/ LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT 319 ERRORS ON UNIVERSAL SURGICAL MANIPULATOR (USM)3. CUSTOMER POWER CYCLED SYSTEM, BUT ERROR RETURNED. TSE WALKED THE CUSTOMER THROUGH AN ADDITIONAL POWER CYCLE, HARD POWER CYCLE, AND EMERGENCY POWER OFF (EPO). SYSTEM AGAIN POWERED ON WITH A 319 ERROR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING THREE USMS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS FUNCTIONING WELL UPON THE START OF THE CASE. THE MAJORITY OF THE PROCEDURE WAS DONE PRIOR TO HAVING ISSUES WITH THE ARM. TECH SUPPORT WAS CALLED, AND WE WERE ADVISED TO DISABLE THE ARM. THE PROCEDURE WAS COMPLETED ON THE XI ROBOT WITH THE THREE ARMS THAT WERE WORKING, OTHER THAN A SLIGHT DELAY TO THE CASE THERE WAS NO INJURY CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095655 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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