BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20552196 · Received October 28, 2024

    Report

    Report Number
    2955842-2024-21231
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 2, 2024
    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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HIGH RESOLUTION STEREO VIEWER (HRSV) WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE HRSV STARTED UP AND FAILED WITH NO VIDEO ON DISPLAY. THE RIGHT EYE ISSUE WAS REPLICATED.

    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 THE HIGH-RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE HRSV INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER WAS COMPLETELY BLACK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM A HARD REBOOT TWICE, WITH NO CHANGE. THE CUSTOMER REPORTEDLY DID NOT HAVE A BACKUP SURGEON SIDE CONSOLE (SSC) AVAILABLE. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTED AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, WITH VISION IN ONLY ONE EYE. PATIENT DEMOGRAPHICS INFORMATION WAS ALSO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923419 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES