BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15143173 · Received August 1, 2022

    Report

    Report Number
    2955842-2022-13287
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 6, 2022
    Report Date
    July 6, 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
    SC
    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 AND FOUND NO ISSUE. THE FSE REVIEWED THE E100 GENERATOR UPGRADE PROCEDURE IN VIRTUAL SUPPORT AND DETERMINED THAT THE SETTING WAS IMPROPERLY CONFIGURED. THE NEST PIC PRESENT WAS REQUIRED TO BE SELECTED AND PROGRAMMED. AFTER FSE COMPLETED THE REPROGRAM, A TEST DRIVE ON THE DA VINCI SYSTEM WAS CONDUCTED AND THE E100 GENERATOR POWERED A VESSEL SEALER INSTRUMENT. THE SYSTEM AND THE E-100 GENERATOR WAS TESTED AND VERIFIED AS READY FOR USE. A LOG REVIEW CONFIRMED THE OCCURRENCE OF A PROCEDURE DATE ON (B)(6) 2022 USING SYSTEM SK4621. THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE AND ISI FSE'S INVESTIGATION. 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 E-100 GENERATOR EXHIBITED A PERSISTENT ERROR AND ANOTHER GENERATOR WAS USED TO COMPLETE THE PROCEDURE. FSE INVESTIGATION CONFIRMED THAT THE E-100 GENERATOR WAS NOT PROPERLY PROGRAMMED. 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 GYNECOLOGICAL SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE E100 GENERATOR WAS "NOT WORKING." THE CUSTOMER STATED THAT THE VESSEL SEALER INSTRUMENT WOULD NOT WORK ON THAT SPECIFIC SYSTEM; HOWEVER, WORKED ON THE OTHERS. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER IF THEY HAD PERFORMED ANY TROUBLESHOOTING. THE CUSTOMER STATED THAT THEY POWER CYCLED BOTH THE E100 GENERATOR AND THE SYSTEM, AS WELL AS REINSTALLING THE INSTRUMENT INTO THE E100 GENERATOR BUT THE ISSUE PERSISTED. THE TSE CONFIRMED THERE WERE NO RELATED ERRORS IN THE LOGS. THE CUSTOMER CONFIRMED THAT THE E100 POWERED ON WITH ILLUMINATED LEDS BUT EXHIBITED AN ISSUE DURING ENERGY ACTIVATION. IT WAS UNABLE TO RECOGNIZE THE INSTRUMENT. FURTHER TROUBLESHOOTING WAS PERFORMED BY USING ANOTHER GENERATOR (ERBE) TO CONNECT THE INSTRUMENT. THE INSTRUMENT PASSED RECOGNITION BUT WAS CONFIRMED TO BE OUT OF USAGE LIFE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED USING THE ERBE INSTEAD OF THE E-100. THE E-100 WAS CHECKED UPON POWERING ON AND EVERYTHING SEEMED FINE UNTIL THE SURGEON TRIED ACTIVATE ENERGY. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AND PROCEDURE DELAY WAS NO MORE THAN 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403815 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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