BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14570534 · Received June 1, 2022

    Report

    Report Number
    2955842-2022-11956
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 4, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 COMPLAINT. THE FSE TESTED THE SYSTEM AND CONFIRMED THE CUSTOMER REPORTED ISSUE. FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) DUE TO UNRECOVERABLE ERRORS. AFTER REPLACEMENT, THE SYSTEM WAS RETESTED, OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. THE IESU GENERATOR UNIT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED POST ENGINEERING EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE AND ISI FSE'S INVESTIGATION THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO ANOTHER DA VINCI SYSTEM AFTER THE START OF THE PROCEDURE DUE TO THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ON THE VSC DISPLAYING NON RECOVERABLE ERRORS. 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 CONVERSION/ABORTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6, AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ERBE HAD A C-34 ERROR. IT WAS NOTED THAT THE CUSTOMER REBOOTED THE ERBE SEVERAL TIMES PRIOR TO CALLING TECH SUPPORT, HOWEVER THE ISSUE REMAINED. THE TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED MULTIPLE ERRORS INCLUDING 25913 AND C-34 ON THE ERBE. THE CUSTOMER CONTINUED WITH THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT ANESTHESIA HAD BEEN ADMINISTERED, PORTS WERE PLACED WHEN THE ISSUE OCCURRED; THE ISSUE DID NOT OCCUR DURING INITIAL SETUP. THE SYSTEM WAS CHECKED UPON POWERING ON AND THE IESU POWERED ON WITHOUT ANY ERRORS. AFTERWARDS THE ERRORS CONTINUED TO POP UP FOLLOWING THIS, THE VISION SIDE CART OR "TOWER" WAS REPLACED. THERE WAS A DELAY IN THE PROCEDURE HOWEVER IT WAS COMPLETED ROBOTICALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WAS REQUESTED, HOWEVER THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631415 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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