BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14126277 · Received April 16, 2022

    Report

    Report Number
    2955842-2022-11082
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    March 16, 2022
    Report Date
    March 16, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE CONFIRMED THE ERROR AS THE STAFF DISABLED THE LEFT MASTER TOOL MANIPULATOR ON THE 2ND SC. REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRMED THE OCCURRENCE OF INFORMATIONAL ERROR CODE ON SC2. IT WAS NOTED THAT THE SURGEON MOVED OVER TO THE OTHER CONSOLE (SC1) TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THEY WOULD RESEAT ALL THE FIBER CABLES IN BETWEEN CASES AND PERFORM A HARD RESET. A FOLLOW UP CALL WAS MADE BY THE FIELD SERVICE ENGINEER (FSE), THE FSE GUIDED THE CUSTOMER TO TEST THE SYSTEM AND CONFIRMED NO ISSUE WITH BOTH SC. NO FURTHER ERROR WAS VERIFIED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING 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: DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE USING A DUAL SURGEON CONSOLE (SC) SETUP, AN ISSUE WAS EXPERIENCED AND THE CUSTOMER HAD TO DISABLE THE MASTER TOOL MANIPULATOR ON SC2 AND SWITCH OVER TO SC1 IN ORDER TO CONTINUE WITH THE PROCEDURE. 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 SEGMENTECTOMY SURGICAL PROCEDURE USING A DUAL SURGEON CONSOLE (SC) SETUP, THE SYSTEM DISPLAYED INFORMATIONAL CODE 26005 ON THE 2ND SC. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE CONFIRMED THE ERROR AS THE STAFF DISABLED THE LEFT MASTER TOOL MANIPULATOR ON THE 2ND SC. REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRMED THE OCCURRENCE OF INFORMATIONAL ERROR CODE ON SC2. IT WAS NOTED THAT THE SURGEON MOVED OVER TO THE OTHER CONSOLE (SC1) TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THEY WOULD RESEAT ALL THE FIBER CABLES IN BETWEEN CASES AND PERFORM A HARD RESET. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE OR ABORTED. THERE WAS NO INTRA-OPERATIVE COMPLICATIONS THAT THE CUSTOMER WAS AWARE OF. THE SYSTEM WAS CHECKED UPON POWERING ON THE SYSTEM FOR FUNCTIONALITY AND THERE WAS NO SYSTEM MALFUNCTION. THE REPORTED ISSUE WAS RESOLVED BY POWER CYCLING THE SYSTEM POST CASE COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974186 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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