BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23176886 · Received September 30, 2025

    Report

    Report Number
    2955842-2025-39897
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 28, 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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 RECEIVED THE USM AND THE FA IS STILL IN PROGRESS. 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. IN ARTEMIS, THE 319 ERROR WAS FOUND INDICATING A NODE NOT FOUND ISSUES ON THE AXES CONTROLLER, CARRIAGE (ACC) CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, DAMAGE WAS FOUND WITH ROLLING LOOP FIBER THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO AN IN-HOUSE SYSTEM WHERE THE 319 ERROR WAS TRIGGERED DURING POWER UP INDICATING FAULT, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE CHECK ALL BOARDS PRESENT WAS FOUND TO BE FAILING ON THE ROLLING LOOP. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS ABA (APPLIED BEHAVIOR ANALYSIS) TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE ROLLING LOOP FIBER IN THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE CUSTOMER STATED ERROR 319 OCCURRED ON USM 4 AND CUSTOMER CAN DISABLE THE USM 4, AND SYSTEM PASSED SELF-TEST. TSE GUIDED CUSTOMER POWER CYCLE THE SYSTEM WITH EMERGENCY POWER OFF (EPO); HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETING AS A THREE ARM PROCEDURE WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PROCEDURE WAS COMPLETED AS A THREE USM ARM PROCEDURE. OTHER INFORMATION WAS REFUSED TO BE PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944348 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A

    Patients

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