BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21465269 · Received February 25, 2025

    Report

    Report Number
    2955842-2025-02113
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 27, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE PROACTIVELY REPLACED BOTH MEDICAL GRADE POWER SUPPLIES (MGPS) AND SYSTEM POWER MANAGER (SPM) THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE POWER SUPPLY SWITCHER AND SPM WAS ANALYZED AND FOUND NO ISSUES DURING VISUAL INSPECTION. POWERED ON INDICATING GREEN LED'S AND NO ERRORS. THERE WAS STILL BATTERY BACK-UP POWER ONCE THE AC CORD WAS UNPLUGGED. THE SPM STATUS SHOWS THE VOLTAGE AND CURRENT IS NORMAL. RAN 20 POWER CYCLES AND IDLED FOR ONE HOUR WITH NO ISSUES. THE SECOND POWER SUPPLY SWITCHER WAS INSTALLED ONTO A GOLDEN SYSTEM AND THE COMPONENT FUNCTIONED AS EXPECTED. THE GOLDEN SYSTEM WAS SET TO RUN POWER/BATTERY TEST FOR 10 MINUTES, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. ONCE THE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. A REVIEW OF THE SITE¿S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 816 INDICATING PSC BATTERY BACKUP FAULT; BATTERY CAPACITY IS LOW OR BOOSTER IS DISABLED AND 824 INDICATING PSC BATTERY LOW AT START UP. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BY THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) HAD THE 'PATIENT CART RUNNING ON BATTERY' MESSAGE AND MOVED THE POWER CORD TO THE OTHER POWER OUTLET. THE CUSTOMER HARD POWER CYCLED THE SYSTEM MULTIPLE TIMES; HOWEVER, THE ISSUE PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND ERRORS 824 AND 816 LOGGED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED AND SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. WHEN SYSTEM POWERED ON, IT APPEARED MESSAGE OF PSC RUNNING ON BATTERY. ISI TECHNICAL SUPPORT WAS CONTACTED FOR TROUBLESHOOTING, AND THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617001 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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