BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15610969 · Received October 14, 2022

    Report

    Report Number
    2955842-2022-14584
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 14, 2022
    Report Date
    September 14, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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 ISI FSE REPLACED SURGEON BACKPLANE (SBP) AND GENERIC CART CONTROLLER (GCC) TO RESOLVE INTERMITTENT NON-RECOVERABLE FAULTS 23 AND 40 ISOLATED TO SSC 2 AND ERRORS 119 AND 810 ON THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE SBP PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "INTERMITTENT CASCADING NON-RECOVERABLE FAULTS ISOLATED TO SSC 2". DURING AN IN-HOUSE FAILURE ANALYSIS, THE TECHNICIAN INSTALLED SBP BOARD INTO PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM, IT FAILED DURING POWER UP WITH ERRORS 31056 AND 5. ERRORS 119 POINTED TO HRSV LOW CURRENT, ERROR 810 POINTED O SWITCH FAULT, ERROR 31056 POINT ERGO TIME-OUT, AND ERROR 5 POINTED TO FAN FAULT. THE PART WAS SCRAPPED DUE TO CONTAMINATION. ISI RECEIVED THE GCC PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "NON-RECOVERABLE FAULT ON THE SYSTEM, TRIGGERING 23, AND RELATED COMMUNICATION FAULTS THROUGH SSC2". DURING IN-HOUSE FAILURE ANALYSIS THE TECHNICIAN INSTALLED GCC BOARD INTO PCA XI SYSTEM AND IT FAILED AT START-UP AN ERROR 22018, WHICH MEANS "OUT OF RANGE ". THE SBP BOARD AND GCC WERE TESTED TOGETHER. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A CHOLECYSTECTOMY PROCEDURE WAS PERFORMED ON SYSTEM SK3939 ON (B)(6) 2022. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY ISI TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR SUPPORT. INVESTIGATION REVEALED MULTIPLE ERRORS 23, 40 AND COMMUNICATION ERRORS OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, 119 FAULTS IN BOTH HIGH RESOLUTION STEREO VIEWER (HRSV) MONITORS AND 810 FAULTS, ALL POINTING TO GPD IN SSC2 WERE NOTED. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT IN THE SYSTEM WAS DISPLAYED. THE CUSTOMER CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY AFTER THE START OF THE PROCEDURE DUE TO MULTIPLE NON-RECOVERABLE FAULTS ON SSC2. 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 CHOLECYSTECTOMY SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT IN THE SYSTEM WAS DISPLAYED. THE SURGEON CALLED IN TO REPORT THE ISSUE. THE SURGEON STATED THAT THEY HAVE ALREADY REMOVED THE INSTRUMENTS, BUT THE ARMS WERE STILL RED. THE SURGEON ALSO STATED THAT HE DID NOT REMEMBER THE FAULT THAT OCCURRED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED TO POWER CYCLE THE SYSTEM. THE SURGEON PERFORMED RECOMMENDED TROUBLESHOOTING STEPS AND WAS ABLE TO POWER ON, INSTALL INSTRUMENTS, AND PROCEED WITH THE CASE. THE SURGEON ALSO STATED THAT HE WAS INFORMED BY THE STAFF THAT THE CONSOLE WAS CAUSED ISSUES PREVIOUSLY. THE ISI TSE VIEWED SYSTEM LOGS AND NOTICED POSSIBLE POWER LOSS TO THE CONSOLE. THE SURGEON CALLED BACK TO REPORT THAT THEY EXPERIENCED MULTIPLE 41014 NON-RECOVERABLE ERRORS. THE CALLER STATED THAT THEY REBOOTED, BUT THE ERROR RETURNED. THE CUSTOMER INFORMED THE ISI TSE THAT THEY WERE HOLDING TISSUE, BUT THERE WAS NO BLEEDING AND THE SURGEON THOUGHT IT SAFE TO TROUBLESHOOT. THE ISI TSE WALKED THE CALLER THROUGH A HARD RESET, WHICH RESOLVED THE ISSUE. THE SYSTEM REBOOTED NORMALLY WITHOUT ERROR. THE OPERATING ROOM (OR) STAFF WAS PROCEEDING WITH THE CASE. THE ISI TSE ADVISED CALLING BACK IF THE ISSUE PERSISTS. THE SURGEON CALLED BACK AGAIN AND REPORTED THEY ENCOUNTERED A NON-RECOVERABLE FAULT FOR THE THIRD TIME DURING THIS PROCEDURE. THE REPORTER EXPLAINED THEY WERE IN THE PROCESS OF CONVERTING TO TRADITIONAL LAPAROSCOPIC SURGERY. ONSITE LOGS REFLECTED COMMUNICATION ERRORS BETWEEN THE VISION SIDE CART (VSC) AND SURGEON SIDE CONSOLE (SSC) 2. THE REPORTER WAS REQUESTING THE ISI FSE TO FOLLOW UP TO ASSIST IN RESOLVING THE ISSUE. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. 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
    2920342 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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