BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 24219217 · Received January 30, 2026

    Report

    Report Number
    2955842-2026-02636
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM). 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. THE MTM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR WAS TRIGGERED INDICATING FAULT ON THE AXIS 8 REPLICATING THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A SURGEON FUNCTIONAL TEST PLATFORM (SFTP) WHERE POWER UP WAS FOUND TO BE FAILING ON THE AXIS 8. ONCE TESTING WAS COMPLETED, THE OPTO BUTTON WAS APPLIED BEHAVIORAL ANALYSIS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE PROCEDURE WAS COMPLETE ROBOTICALLY JUST WITH LIMITED MOMENT BY DEFECTIVE ARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE UTILIZING AN XI SYSTEM, AN OPERATING ROOM (OR) STAFF MEMBER CONTACTED TECHNICAL SUPPORT TO REPORT THAT UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 1 BECAME UNRESPONSIVE, PREVENTING THE PHYSICIAN FROM MOVING IT. ARM 1 STOPPED ARTICULATING, AND ONLY AFTER APPROXIMATELY FOUR MINUTES, THE PHYSICIAN WAS ABLE TO REGAIN LIMITED MOVEMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND IDENTIFIED ERRORS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML). SUBSEQUENTLY, THE CUSTOMER CALLED BACK TO REPORT THAT THE SCHEDULED PROCEDURE WAS PERFORMED DESPITE ONGOING ISSUES WITH THE CLUTCH BUTTONS ON THE MTML. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED PATIENT 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
    596899 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-11 N/A 00886874115374

    Patients

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