BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15673409 · Received October 26, 2022

    Report

    Report Number
    2955842-2022-14859
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    September 26, 2022
    Report Date
    September 26, 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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON SITE TO CHANGE OUT THE IESU DUE TO ISSUE WITH MONO/BIPOLAR ENERGY. THE FSE FOUND BIPOLAR PORTS WERE LOOSE AND INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS REPLACED AND SYSTEM IS TESTED AND READY FOR USE. THE FSE REPLACED (IESU) SERIAL NUMBER: (B)(4) WITH SERIAL NUMBER: (B)(4) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT REPLICATE THE MONOPOLAR ENERGY ISSUE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. A PROCEDURE LOG REPORT REVIEW WAS PERFORMED. THE COLORECTAL PROCEDURE WAS COMPLETED ON (B)(6) 2022 VIA SYSTEM (B)(4). A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO ANOTHER DV SYSTEM AFTER THE START OF THE PROCEDURE DUE TO THE MONOPOLAR ENERGY ISSUES WITH THE GENERATOR. 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 OTHER COLORECTAL SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE MONOPOLAR ENERGY IS NOT FIRING AS EXPECTED. THE CALLER STATED THAT THEY ARE HEARING THE TONE BUT NO ENERGY IS PRESENT. PRIOR TO CONTACTING TECH SUPPORT, CALLER STATED THAT THEY TRIED ANOTHER INSTRUMENT AND MONOPOLAR ENERGY CABLE BUT THE ISSUE REMAINED. SITE ALSO WENT FROM AN EFFECT LEVEL OF 3 TO 5 AND ISSUE STILL REMAINED. DURING THE CALL THE STAFF POWER CYCLED THE ERBE GENERATOR BUT THE ISSUE REMAINED. THE TSE THEN HAD CALLER TRY THE SECOND MONOPOLAR PORT BUT ISSUE PERSISTED. TSE ADVISED THAT THEY CAN TRY TO CONNECT THE FORCE TRIAD GENERATOR TO GET MONOPOLAR ENERGY TO WORK. THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED BACK TO FIGURE OUT HOW TO CONNECT THE FORCE TRIAD. TSE INFORMED CALLER THAT THEY HAVE TO USE THE BLUE VALLEYLAB ENERGY CABLE. OPERATING ROOM STAFF IS SEARCHING FOR THE CABLE AND WILL CALL BACK IF FURTHER ASSISTANCE IS NEEDED. CSR CALLED BACK AGAIN TO REPORT THAT THE STAFF HAD DECIDED TO SWAP OUT THE VISION SIDE CART (VSC). THE PROCEDURE WAS CONVERTED TO ANOTHER DV AND COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND THE REPORTER WAS ABLE TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802820 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES