BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19639547 · Received June 28, 2024

    Report

    Report Number
    2955842-2024-16454
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 6, 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
    TW
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. FSE REPLACED PERSONALITY MODULE SURGEON CONSOLE (PMSC) BOARD TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RUNNING VIDEO TEST, 1 MINUTE SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. DURING THE POWER CYCLES THE TECHNICIAN REPLICATED THE REPORTED FAILURE. THE TROUBLESHOOTING FOUND THE SYSTEM CANNOT DETECTED THE LEAF WHICH LOCATED ON THE PMSC MODULE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THERE WAS NO IMAGE IN THE LEFT EYE OF THE CONSOLE. THE VISION SIDE CART (VSC) IMAGES WERE NORMAL FOR BOTH LEFT AND RIGHT SIDES. THE CUSTOMER DISCONNECTED THE DVI CABLES TO THE SURGEON SIDE CONSOLE (SSC) AND REBOOTED THE SYSTEM, BUT THE ISSUE PERSISTED. THE TECHNICAL SERVICE ENGINEER (TSE) FOUND AN ERROR 48200 IN THE LOGS POINTING TO THE PERSONALITY MODULE SURGEON CONSOLE (PMSC). THE TSE RECOMMENDED THE CUSTOMER TO CHANGE TO 2D VIEWER MODE TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PAUSED THE PROCEDURE AND WAITED FOR THE FIELD SERVICE ENGINEER (FSE) TO FIX THE ISSUE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851548 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-16 N/A 00886874110744

    Patients

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