BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19474106 · Received June 6, 2024

    Report

    Report Number
    2955842-2024-15298
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 8, 2024
    Report Date
    May 8, 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 REPORTED EVENT WAS ADDRESSED AND RESOLVED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE SPOKE WITH THE CUSTOMER THE FOLLOWING DAY AND WALKED THEM THROUGH A HARD POWER CYCLE OF ALL FOUR SYSTEM CARTS. CUSTOMER CONFIRMED CARTS POWERED ON AS NORMAL AND THAT SYSTEM GAVE 'DA VINCI IS READY' MESSAGE. CUSTOMER ELECTED TO CONTINUE USING SSC-1 AS NORMAL. FSE FOLLOWED UP WITH THE OR MANAGER LATER IN THE DAY TO CONFIRM THERE WERE NO ADDITIONAL ISSUES. THEY CONFIRMED CASES WERE PROCEEDING NORMALLY. 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 SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED THE CONSOLE GRIPS SHAKING AND MAKING A WEIRD NOISE WITHOUT SURGEON INPUT. CALLER STATED THAT ISSUE WAS WITH SURGEON SIDE CONSOLE-1 AND THAT THEY MOVED THE SURGEON OVER TO ANOTHER CONSOLE THAT DID NOT HAVE ISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM INITIALLY POWERS ON WITHOUT ERRORS. THE CAUSE OF ISSUE WAS UNKNOWN AND HAD NOT COME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7985 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-20 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES