BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15656395 · Received October 22, 2022

    Report

    Report Number
    2955842-2022-14795
    Event Type
    Injury
    Date Received
    October 22, 2022
    Date of Event
    September 22, 2022
    Report Date
    September 22, 2022
    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
    NY, US
    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 COMPLAINT. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PART(S) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ISSUE OF ERRORS C-30, C-38, M-11 AND M-18 IN THE LOGS COULD NOT BE REPLICATED. FAILURE ANALYSIS CONFIRMED THE UNIT WAS RECEIVED AS A DEFECTIVE FRU. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER AS A SAFETY PRECAUTION FOR FURTHER INVESTIGATION. UPON VISUAL INSPECTION, THE BEZEL WAS CRACKED, DEEP SCRATCHES WERE NOTED ON THE TOP COVER AND THE HEAT SINK WAS DISCOLORED. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 ON SYSTEM SK0238. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED TO OPEN SURGERY AFTER THE START OF THE PROCEDURE DUE TO THE ESU NOT FUNCTIONING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN FROM OUTSIDE THE ROOM TO REPORT THEY HAD AN ERROR MESSAGE ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU). THE CUSTOMER SAID THEY ARE GETTING A C-30 ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE ERROR LOGS AND FOUND MULTIPLE C-30/C38/M-11/M-18. THE TSE RECOMMENDED THE CUSTOMER REBOOT THE IESU TO SEE IF THE ERROR CLEARS. THE CUSTOMER CALLED INTO THE ROOM AND TOLD THEM TO TRY AND REBOOT THE IESU. THE CUSTOMER SAID THEY WOULD CALL BACK IN IF THEY HAD ANY OTHER ISSUES. THE CUSTOMER CALLED BACK IN AND HAD QUESTIONS ABOUT CHANGING OUT THE VISION SIDE CART (VSC) IESU. THE TSE ADVISED THE CUSTOMER THEY WOULD NEED TO SWAP OUT VSCS TO DO THIS AND ADVISED THE SURGEON IT WOULD TAKE 20 MINUTES TO SWAP OUT. THE SURGEON OPTED TO CONVERT TO OPEN. THE PROCEDURE WAS CONTINUING WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453898 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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