BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21436330 · Received February 21, 2025

    Report

    Report Number
    2955842-2025-01967
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 27, 2025
    Report Date
    January 27, 2025
    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
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE VIDEO PROCESSOR (VP) WAS INSTALLED ONTO A GOLDEN SYSTEM (IS 4200) WHERE THE ERROR 45312 WAS TRIGGERED INDICATING FAULT ON THE DWA BOARD, REPLICATING THE REPORTED EVENT. THE GOLDEN SYSTEM WAS SET TO RUN VIDEO TEST, 10 MINUTES SINE CYCLES, 10 POWER CYCLES AND SITTING IDLE FOR 1 HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED AND VERIFIED THE VP TO BE THE SOURCE OF THE FAULT. ROOT CAUSE IS ATTRIBUTED TO THE VCA1 ON THE DWA BOARD. THE ENDOSCOPE CONTROLLER (EC) WAS INSTALLED ON THE GOLDEN PCA SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED FAILURE. THE EC WAS INSTALLED INTO THE TEST SYSTEM AND RUNNING VIDEO TEST FOR 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR.

    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 VIDEO PROCESSOR AND ENDOSCOPE CONTROLLER TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION.

    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 SLIDING HIATAL HERNIA SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY EXPERIENCED A LOSS OF VISION IN THE ENDOSCOPE'S RIGHT EYE. PRIOR TO CALLING, THE USER TRIED TWO DIFFERENT ENDOSCOPES, CLEANED CONNECTORS ON BOTH THE ENDOSCOPE CONTROLLER AND ENDOSCOPE, AND CHECKED FOR VISIBLE DAMAGE, CONFIRMING THAT THERE WAS NONE. THE TSE REVIEWED THE SYSTEM ERROR LOGS AND CONFIRMED THE OCCURRENCE OF ERROR 45312, POINTING TO THE VISION PROBLEM ON THE RIGHT EYE. THE USER PROCEEDED WITH THE PROCEDURE AS PLANNED WITH 2D VISION. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044282 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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