BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24709890 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19104
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    June 3, 2025
    Report Date
    March 26, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) DUE TO THE ERROR. 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. IN THE SYSTEM LOGS, ERROR 1162 WAS FOUND INDICATING A CANNULA SENSOR FAULT ON THE USM AXES CONTROLLER SPAR (ACS) BOARD, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A KNOWN WORKING SYSTEM WHERE THE ERROR 1162 WAS TRIGGERED, INDICATING A FAULT ON THE CANNULA. THE USM WAS INSTALLED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE THE CANNULA WAS FOUND TO BE FAILING ON THE ACS BOARD. ONCE TESTING WAS COMPLETED, THE CANNULA FLAT FLEX CABLE WAS TESTED AND VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE IS ATTRIBUTED TO AN ISSUE WITH THE CANNULA FLAT FLEX CABLE IN THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING (POST-ANESTHESIA) A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 HAD ERROR 1162. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE HAD THE CUSTOMER REMOVE CANNULAS, POWER DOWN THE SYSTEM INCLUDING CIRCUIT BREAKER AND EMERGENCY POWER OFF (EPO) ON PATIENT SIDE CART (PSC) AND THEN RESTART, BUT THE ISSUE WAS NOT RESOLVED. THE TSE ADVISED THE CUSTOMER TO USE THE REMAINING THREE USM ARMS. HOWEVER, THE SURGEON ELECTED TO CONVERT TO OPEN SURGERY. THERE WAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE ADDITIONAL INFORMATION: THE REPORTER INDICATED THAT THE ERROR OCCURRED WHILE THE PATIENT WAS UNDER ANESTHESIA BUT HAD NOT YET BEEN TRANSFERRED TO THE OPERATING ROOM. AS PER HOSPITAL PROTOCOL, PATIENTS RECEIVE ANESTHESIA IN A DESIGNATED ROOM BEFORE BEING MOVED TO THE OPERATING THEATER, AND AT THIS POINT, THE PORTS HAD NOT BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122102 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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