BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15612727 · Received October 15, 2022

    Report

    Report Number
    2955842-2022-14623
    Event Type
    Malfunction
    Date Received
    October 15, 2022
    Date of Event
    September 15, 2022
    Report Date
    September 15, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE IDENTIFIED THAT THE ERBE WAS NOT FIRING WITH THE BOTTOM MONOPOLAR PORT. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE HAS BEEN CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT WAS FOUND TO HAVE A HAIRLINE CRACK ON THE FRONT BEZEL. THE UNIT WILL BE RETURNED TO THE MANUFACTURER FOR REPAIR. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE FIELD SERVICE ENGINEER (FSE) REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) AFTER THE START OF THE PROCEDURE DUE TO THE BOTTOM MONOPOLAR PORT NOT WORKING. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BOTTOM MONOPOLAR PORT ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS NOT WORKING. THE CUSTOMER STATED THAT SITE WAS GETTING A QUESTION MARK ICON WHEN AN INSTRUMENT IS CONNECTED. CALLER STATED THAT SITE TRIED REBOOTING THE IESU AND REPLACING THE MONOPOLAR CORD WITH NO CHANGE. SITE MOVED THE MONOPOLAR CORD TO THE TOP PORT AND THEN WERE ABLE TO USE MONOPOLAR ENERGY. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED LOGS AND DID NOT NOTE ANY ASSOCIATED ERRORS. THE SITE WAS CONTINUING BY USING THE TOP MONOPOLAR PORT, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE DA VINCI ROBOTICS COORDINATOR, THE FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE AND REPLACED THE PART. THERE HAVE BEEN NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744021 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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