BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24395309 · Received February 19, 2026

    Report

    Report Number
    2955842-2026-05048
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 28, 2026
    Report Date
    May 6, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 SYSTEM LOGS, THE 319 ERROR WAS FOUND INDICATING NODE 186 IS NOT PRESENT AT STARTUP #ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) AXES CONTROLLER CARRIAGE (ACC) AXIS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THE ROLLING LOOP FIBER ASSEMBLY FLAT FLEX CABLE (FFC) IS TORN. THE USM WAS INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE FIBER TEST AND CHECK ALL BOARD PRESENT WAS FOUND TO BE FAILING ON THE ACC AXIS. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FFCS WAS FURTHER INSPECTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT REGARDING AN ERROR ON ARM 2 WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO THE ROLLING LOOP FIBER ASSEMBLY.

    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 ERRORS. 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.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS ATTRIBUTED TO A DAMAGED ROLLING LOOP CABLE, CAUSING COMMUNICATION ISSUES WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM)2, AXES CONTROLLER CARRIAGE (ACC).

    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, A SURGEON INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 319 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AFTER REMOVING AND RE-INSERTING CAMERA. THE TSE HAD THE CUSTOMER PERFORM HARD POWER CYCLE THE SYSTEM, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER DISABLED USM 2 TO CONTINUE WITH THE REMAINING THREE USM ARMS. 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
    456047 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1