BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25051506 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-23357
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE VIDEO PROCESSOR (VP) WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED AND REPLICATED. IN THE SYSTEM LOGS, THE ERROR 319 WAS FOUND, CONFIRMING THE FAILURE OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, THE UNIT WAS FOUND TO HAVE MISSING AIR FILTER. THE VP WAS INSTALLED IN THE GOLDEN SYSTEM, UPON THE POWER ON, THE SYSTEM FAILED WITH ERROR 319. THE VIDEO CAMERA INTERFACE (VCI) #1 WAS NOT PRESENTED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT DUAL WINDOW APPLIANCE (DWA) BOARD WAS THE POTENTIAL SOURCE OF THE REPORTED ISSUE. THE COMPLAINT WAS CONFIRMED AND REPLICATED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL ISSUES RESULTED FROM A DWA BOARD LOCATED ON VP.

    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 VIDEO PROCESSOR (VP) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS RECEIVED THE VP FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. 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

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE USING AN XI SYSTEM, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A SURGEON SIDE CONSOLE (SSC) HAD BEEN MOVED OUT OF THE ROOM, AFTER WHICH THE SYSTEM WAS POWERED BACK ON AND A NON-RECOVERABLE FAULT 319 OCCURRED, WITH ERROR 319 ON MULTIPLE CARTS AND ERROR 54 ON MULTIPLE BLUE FIBER CABLES (BFC)S NOTED IN THE LOGS. TSE FIRST WALKED THE USER THROUGH CONFIRMING PROPER SEATING OF ALL BFCS, PERFORMING A HARD POWER CYCLE OF THE CARTS, AND RESEATING AN ORANGE FIBER CABLE; AFTER THIS, THE SYSTEM POWERED ON BUT PRESENTED ERROR 311 ON VIDEO PROCESSOR (VP). TSE THEN HAD THE USER DISCONNECT THE BFCS AND POWER EACH CART ON IN STAND-ALONE MODE, WHICH SHOWED NO ISSUES. TSE NEXT INSTRUCTED THE USER TO POWER OFF THE SSC AND PATIENT SIDE CART (PSC) AND, WITH THE VISION SIDE CART (VSC) POWERED ON, RECONNECT THE PSC AND THEN SSC BLUE FIBER CABLES, AFTER WHICH THE SYSTEM ANNOUNCED READINESS. TSE EXPLAINED THAT THE BEHAVIOR COULD NOT BE FULLY EXPLAINED AND REQUESTED AN ADDITIONAL POWER CYCLE TO CONFIRM THE SYSTEM COULD COMPLETE SELF-TEST; WHEN THIS WAS DONE, ERROR 319 REAPPEARED ON MULTIPLE CARTS. THE USER ELECTED TO ABORT TO ANOTHER DV SYSTEM TO PERFORM THE PROCEDURE AS PLANNED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183823 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1