BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 21572714 · Received March 11, 2025

    Report

    Report Number
    2955842-2025-05760
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 MONITORED THE SYSTEM PERFORMANCE DURING THE PROCEDURE AND THE SYSTEM FUNCTIONED WITHOUT ISSUE. AFTER THE CASE WAS OVER, THE FSE REPLACED THE VISION SIDE CART (VSC) VISION TOWER AND CONFIRMED THE SYSTEM WAS READY FOR USE. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE EVENT INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ISI DID RECEIVE THE VISION TOWER INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE VISION TOWER WAS ANALYZED AND AN ERROR WAS FOUND IN RECORDED LOGS AND FAILURE WAS REPLICATED ON SITE. THE SYSTEM WAS POWER CYCLED, AND THE SYSTEM POWERED UP WITHOUT ANY ERRORS. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO PROBLEM RELATED TO THE REPORTED ISSUE. DURING SYSTEM TESTING, THE SYSTEM WAS POWER CYCLED 10 TIMES AND IDLED FOR OVER 48 HOURS WITHOUT TRIGGERING ANY FAULTS RELATED TO THE REPORTED EVENT. THE VIDEO DISPLAY CONTROLLER NETWORK (VDCN) WAS IDENTIFIED DURING THE INVESTIGATION AS A POTENTIAL CAUSE FOR THE REPORTED EVENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED A POSSIBLE RELATED SYSTEM ERROR INDICATING THAT "A NODE CONFIRMED TO BE PRESENT DID NOT RESPOND DURING SYSTEM STARTING UP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC SLEEVE SURGICAL PROCEDURE, THE ENTIRE SYSTEM SHUT DOWN UNEXPECTEDLY. ONE UNKNOWN INSTRUMENT WAS GRASPING THE GALLBLADDER AT THE TIME OF THE RESTART, WHICH WAS LEFT IN PLACE DURING THE REBOOT. AFTER THE SYSTEM RESTARTED, BLEEDING WAS IDENTIFIED AT THE GALLBLADDER. THE BLEEDING WAS NOT PRESENT BEFORE THE SHUTDOWN. THE INSTRUMENT RELEASE KEY (IRK) WAS SUCCESSFULLY UTILIZED TO RELEASE THE GALLBLADDER TISSUE FROM THE JAWS OF THE INSTRUMENT. ALL INSTRUMENTS WERE REENGAGED WITHIN THE SYSTEM, AND THE BLEEDING WAS ABLE TO BE CONTROLLED WITH CAUTERY. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO FURTHER COMPLICATIONS. THE PATIENT IS REPORTED TO BE DISCHARGED AND RECOVERING WELL.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339933 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

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