BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18956283 · Received March 21, 2024

    Report

    Report Number
    2955842-2024-12530
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 26, 2024
    Report Date
    February 26, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE HRSV, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE THE REPORTED COMPLAINT. THE HRSV WAS TESTED ON AN IN-HOUSE SYSTEM. THE SYSTEM WAS POWER CYCLED 10 TIMES AND THEN LEFT IDLE FOR ANOTHER 30 MINUTES. NO ISSUE OCCURRED. THE IMAGE WAS CLEAR AND NORMAL. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE RIGHT IMAGE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV) WAS LOST. THE CUSTOMER POWER CYCLED THE SYSTEM TO RESOLVE THE ISSUE ONCE; HOWEVER, THE ISSUE REOCCURRED AFTER A MOMENT. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE FOUND ERROR 119 IN THE LOGS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE PROCEDURE COULD BE COMPLETED WITH THE SAME DA VINCI SYSTEM CONFIGURATION. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554926 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-13 N/A 00886874110744

    Patients

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