BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22506678 · Received July 15, 2025

    Report

    Report Number
    2955842-2025-29763
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 24, 2025
    Report Date
    June 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED ERROR LOGS, AND THEY WERE CLEAR. THE ISI TSE HAD THE CUSTOMER TO SHUTDOWN SYSTEM AND RESEAT DIGITAL VIDEO INTERFACE (DVI) FIBERS CONNECTIONS ON THE CORE. AFTER THE SYSTEM WAS RESTARTED, THE IMAGE ON THE TOUCH SCREEN WAS CORRECT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, GREEN LINES WERE PRESENT ON THE TOUCH SCREEN. THE NURSE CALLED IN AFTER THE SURGERY WAS CONVERTED DUE TO ANATOMY TO REPORT THAT GREEN LINES WERE PRESENT ON THE TSC. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THAT THE FAULT WAS ISOLATED TO THE VISION CART MONITOR AND NOT PRESENT WITHIN THE SURGEON CONSOLE VIEWER. THE TSE REVIEWED ERROR LOGS, AND THEY WERE CLEAR. THE TSE ASKED THE CUSTOMER TO SHUT DOWN THE SYSTEM AND RESEAT THE DIGITAL VIDEO INTERFACE (DVI) FIBER CONNECTIONS ON THE CORE. AFTER THE SYSTEM RESTARTED, THE IMAGE ON THE TSC WAS CORRECT. THE SYSTEM WAS READY TO USE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572340 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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