BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23494222 · Received November 7, 2025

    Report

    Report Number
    2955842-2025-44327
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 14, 2025
    Report Date
    April 6, 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
    FR
    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 WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIDEO PROCESSOR (VP) AND ENDOSCOPE CONTROLLER (EC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE CONTROLLER (EC) HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS. VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE VIDEO PROCESSOR (VP) WAS INSTALLED ON A GOLDEN SYSTEM (IS 4200), WHERE THE REPORTED FAILURE WAS TRIGGERED ON THE VIDEO CAMERA ALGORITHM PROCESSOR (VCA) 1 OF THE DUAL WINDOW APPLIANCE (DWA) BOARD BY FAULTS INDICATED ON THE VP, SUCCESSFULLY REPLICATING THE REPORTED EVENT. THE GOLDEN SYSTEM WAS THEN SUBJECTED TO A SERIES OF VIDEO TESTS: A 10-MINUTE SINE CYCLE, 10 POWER CYCLES, AND A 2 HOUR IDLE PERIOD. AFTER COMPLETING THESE TESTS, THE SYSTEM ERROR LOGS WERE REVIEWED, WHICH CONFIRMED THE DWA BOARD AS THE SOURCE OF THE FAULT. BASED ON THESE FINDINGS, FA CONCLUDED THAT THE DWA BOARD ON THE VP WAS THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGICAL VIEW WAS TWITCHING ON ALL SCREENS. THE SITE REPLACED THE ENDOSCOPE AND RESTARTED THE SYSTEM, BUT ISSUE PERSISTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND THE ERROR PATTERN 48314/48351 POINTING TO COMMUNICATION BETWEEN VIDEO PROCESSOR (VP) AND ENDOSCOPE CONTROLLER (EC) IN THE LOGS. THE TSE ASKED THE USER TO REPLACE THE ENDOSCOPE AND TO POWER CYCLE THE SYSTEM, THE BEHAVIOR REMAINED. 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
    11021 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-48 N/A 00886874110898

    Patients

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