BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17039833 · Received June 1, 2023

    Report

    Report Number
    2955842-2023-15450
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    June 12, 2020
    Report Date
    June 12, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE CONFIRMED THAT THE BOTTOM MONOPOLAR PORT IS INOPERABLE AND THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS REPLACED TO ADDRESS THE ISSUE. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED AND REPRODUCED THE REPORTED ISSUE DURING IN-HOUSE TESTING. THE IESU WAS UNABLE TO DETECT MONOPOLAR TEST INSTRUMENTS ON MONOPOLAR PORT 2.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI-ASSISTED GYNECOLOGY/ONCOLOGY PROCEDURE THERE WERE ISSUES WITH MONOPOLAR PORT 2 ON THE ERBE. THE SITE EXPLAINED THAT ENERGY WOULD NOT FIRE AND THE SURGICAL STAFF ADDRESSED THE ISSUE BY MOVING TO PORT 1. TECHNICAL SUPPORT ASSOCIATE (TSA) ASKED IF THEY TRIED TO MOVE BACK TO PORT 2 TO TEST AFTER PROCEDURE AND CALLER STATED NO. THE TSA REVIEWED THE SYSTEM LOGS AND NOTED 25913 ERRORS ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). NO FURTHER TROUBLESHOOTING WAS ATTEMPTED AS THE PROCEDURE WAS COMPLETED. THE CUSTOMER EXPLAINED THAT THE SURGEON CONVERTED THE CASE DUE TO PATIENT ANATOMY AND THE CONVERSION WAS NOT DUE TO THE ISSUE WITH THE SYSTEM/ERBE. THERE WAS NO REPORTED PATIENT INJURY OR HARM. INTUITIVE SURGICAL, INC. (ISI) COMPLETED FOLLOW-UP AND CONFIRMED WITH ROBOTICS COORDINATOR THAT THE PROCEDURE WAS A GYNECOLOGY/ONCOLOGY CASE AND NOT TOTAL BENIGN HYSTERECTOMY PROCEDURE. THERE WAS NO MALFUNCTION WITH THE DA VINCI XI SYSTEM, BUT THERE WAS AN ISSUE WITH THE ERBE. TROUBLESHOOTING WAS PERFORMED WITH TECHNICAL SUPPORT, BUT THE ISSUE COULD NOT BE RESOLVED. THE SURGICAL STAFF DID NOT HAVE ISSUES DURING SET UP OF THE SYSTEM AND THEY TRIED ADJUSTING THE INSTRUMENTS AND DRAPES, BUT THE ISSUE PERSISTED WITH THE ERBE. THE SURGICAL STAFF CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO THE ISSUE WITH THE ERBE AND WAS COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296417 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES