BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24721433 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19593
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 8, 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
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE FIRST UNIVERSAL SURGICAL MANIPULATORS (USM) WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED AND REPLICATED. IN THE SYSTEM LOGS, THE ERROR 23000 WAS FOUND INDICATING A USM3 FAULT, CONFIRMING THE FAILURE OCCURRED IN FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE CURRENT WAS FOUND TO BE FAILING ON THE PITCH AXIS, REPLICATING THE REPORTED EVENT. ONCE TESTING WAS COMPLETED, THE PITCH SEARCHLIGHT BOARD AND PITCH SEARCHLIGHT FLAT FLEX CABLE (FFC) WERE TESTED AND VERIFIED TO BE THE SOURCE OF THE FAULT. THE SECOND USM WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED AND REPLICATED. IN THE SYSTEM LOGS, THE ERRORS 31226 WERE FOUND, INDICATING COMMUNICATION ISSUES BY USM2, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A PFTP WHERE THE FIBER TEST WAS FOUND TO BE FAILING ON THE CLOCK SPRING FIBER CABLE, REPLICATING THE REPORTED EVENT. ONCE TESTING WAS COMPLETED, THE CLOCK SPRING FIBER WAS TESTED AND VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED AND REPLICATED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO SENSOR ERRORS RESULTED FROM A FAULTY PITCH SEARCHLIGHT BOARD AND PITCH SEARCHLIGHT FFC AND ATTRIBUTED TO COMMUNICATION ERRORS CAUSED BY A FAULTY CLOCK SPRING FIBER CABLE. THIS ISSUE CAN BE RESOLVED BY REPLACING THE AFFECTED USMS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO HARM TO THE PATIENT.

    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 TWO UNIVERSAL SURGICAL MANIPULATORS (USM) DUE TO UNRESPONSIVENESS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USMS FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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 SURGICAL PROCEDURE USING AN XI SYSTEM, THE STAFF ENCOUNTERED AN ISSUE WITH UNIVERSAL SURGICAL MANIPULATOR (USM3) NOT RESPONDING. ALTHOUGH THE ARM INITIALLY FAILED TO RESPOND, CLUTCHING AND UNCLUTCHING RESTORED ITS FUNCTIONALITY. THE SAME ISSUE REOCCURRED LATER IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305217 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1