BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21225526 · Received January 23, 2025

    Report

    Report Number
    2955842-2025-00720
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    January 2, 2025
    Report Date
    January 2, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE WAS A FAILURE OF THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR.

    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. FSE REPLACED HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE HRSV MONITOR WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ISSUE WAS REPLICATED. IN LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE HRSV WAS INSTALLED ONTO A PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM POWERED WITH A BLANK SCREEN.

    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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE RIGHT EYE WAS BLACK IN THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED PERFORMING A HARD RESTART OF THE SURGEON SIDE CONSOLE (SSC) AND RESEATING THE BLUE FIBER CABLE. THE PROCEDURE WAS BEING COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859099 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

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