BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17906106 · Received October 10, 2023

    Report

    Report Number
    2955842-2023-19067
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CUSTOMER CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO POWERING DOWN OF THE PATIENT SIDE CART (PSC). HOWEVER, THROUGH TROUBLESHOOTING, IT WAS DETERMINED THAT THE PSC CIRCUIT BREAKER WAS SET TO THE OFF POSITION, AND THIS CAUSED THE PSC TO RUN IN BATTERY MODE AND EVENTUALLY TO LOSE POWER. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO SET THE PSC CIRCUIT BREAKER TO THE ON POSITION TO CORRECT THE ISSUE. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT THE SYSTEM WAS RUNNING IN BATTERY MODE. CALLER TOOK NO ACTION. SHORTLY AFTER STARTING THE PROCEDURE, THE PATIENT SIDE CART (PSC) POWERED DOWN. THE CUSTOMER MANAGED TO REMOVE THE INSTRUMENTS FROM THE PATIENT AND THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE CUSTOMER CALLED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER THE CUSTOMER ALREADY CONVERTED THE PROCEDURE. ACCORDING TO THE CUSTOMER, THIS SURGERY HAD A HIGH RISK TO BE CONVERTED TO AN OPEN SURGERY RIGHT FROM THE BEGINNING. DURING TROUBLESHOOTING, IT TURNED OUT THAT THE CIRCUIT BREAKER FROM THE PSC HAD BEEN SET TO THE OFF POSITION. AFTER CORRECTING THAT ISSUE, THE PSC WAS WORKING. ITS BATTERY WAS CHARGING. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO PATIENT HARM. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TUMOR WAS QUITE LARGE. THE HIGH RISK OF CONVERSION WAS ALREADY KNOWN, AND THE PATIENT WAS PREPARED FOR AN OPEN PROCEDURE FROM THE VERY BEGINNING. THE PATIENT TOLERATED THE OPEN PROCEDURE VERY WELL. THE PATIENT WAS NOT INJURED. PORTS WERE PLACED AT THE TIME OF THE CONVERSION TO OPEN SURGERY. DURING SET UP, THE CUSTOMER HAD IDENTIFIED THAT THE SYSTEM WAS RUNNING ON BATTERY POWER, BUT THE CAUSE COULD NOT BE IDENTIFIED. THE SYSTEM WAS CHECKED BEFORE USE AND IMMEDIATELY CALLED THE HOTLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335123 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

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