BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 13293738 · Received January 19, 2022

    Report

    Report Number
    2955842-2022-10100
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 28, 2021
    Report Date
    December 28, 2021
    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
    SP
    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. TO CORRECT THE ISSUE, FSE REPLACED THE SURGEON HEAD SENSOR RX. IN ADDITION, FSE ALSO REPLACED HEAD SENSOR TRANSMITTER, TWO DAMAGED RELEASE TABS AND ONE UNIVERSAL SURGICAL MANIPULATOR (USM) COVER. FSE VERIFIED SURGEON BACK PLANE (SBP) CONNECTORS AND PERFORMED A P9F SOFTWARE UPGRADE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE REPLACED COMPONENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AT THE TIME OF THE CALL INTO TECHNICAL SUPPORT. THE LOGS CONFIRMED THE REPORTED ERRORS. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IS NOT AVAILABLE. FIELDS ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE REPLACED COMPONENT FOR EVALUATION, HOWEVER, FAILURE ANALYSIS INVESTIGATION HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. ON 24-JAN-2022, ADDITIONAL INFORMATION ABOUT THE EVENT WAS OBTAINED FROM THE DISTRIBUTOR/ABEX: THE ALLEGED ISSUE WAS IDENTIFIED PRIOR TO STARTING (POST-ANESTHESIA); PORTS WERE NOT YET PLACED. TROUBLESHOOTING WAS NOT COMPLETED. WHEN POWERED ON, A SYSTEM CHECK WAS PERFORMED AND NO ERROR WAS OBSERVED. THE SURGEON WAS ABLE TO SEE THROUGH THE HRSV (HIGH RESOLUTION STEREO VIEWER) AND GO INTO FOLLOWING MODE. THE OR HAD A DUAL CONSOLE SET-UP. THE REPORTER CLARIFIED THAT WHEN THE ISSUE OCCURRED, THE OR TEAM DISCONNECTED THE AFFECTED SURGEON SIDE CONSOLE (SSC). FOLLOWING THIS, THE ALLEGED PROBLEM DID NOT REOCCUR. THE HOSPITAL DECLINED TO PROVIDE PATIENT INFORMATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY RPMS SUPERVISOR. INVESTIGATION REVEALED THE FOLLOWING: ON (B)(6) 2021, THE SYSTEM POWERED ON IMMEDIATELY INDICATING THERE WAS AN ERROR 1150 ON THE SSC WITH SERIAL#: (B)(6) AT 9:34AM. LOGS INDICATED THERE WAS SOME TROUBLESHOOTING BEING PERFORMED ON THE SYSTEM WITH POWER CYCLES AND BLUE FIBER CABLES BEING DISCONNECTED/CONNECTED FROM POWER ON (55100) AT 9:4AM ALL THE WAY TO START OF PROCEDURE (55200) AT 11:21AM. AT THE START OF PROCEDURE, THE SYSTEM HAD BOTH SSCS (B)(6) CONNECTED. MULTIPLE ERRORS PERSISTED ON THE SYSTEM THROUGHOUT THE PROCEDURE UNTIL END OF PROCEDURE (55201) AT 1:55PM. A DEEPER SEARCH ON THIS SYSTEM INDICATES THAT THE CUSTOMER WAS AWARE OF ERROR 1150 SINCE IT FIRST OCCURRED THE DAY BEFORE ((B)(6) 2021 AT 2:37PM).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. D02 - INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SURGEON HEAD SENSOR RX ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. DURING VISUAL INSPECTION, FAILURE ANALYSIS FOUND THE UNIT'S J2 CONNECTOR WAS DAMAGED. AS A RESULT OF THE DAMAGED CONNECTOR, THE UNIT COULD NOT CONNECT TO THE TEST SYSTEM CABLE. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT COLECTOMY SURGICAL PROCEDURE, THE SYSTEM DISPLAYED AN ERROR 1150. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED ERROR 1150. THE TSE INSTRUCTED THE CUSTOMER TO PERFORM HARD POWER CYCLE, EMERGENCY POWER OFF (EPO), AND RESEATING THE BLUE FIBER CABLE (BFC). AFTER REBOOTING THE SYSTEM, THE ERROR CLEARED. THE TSE LATER FOLLOWED UP WITH THE CUSTOMER AFTER CHECKING THE LOGS, THE ERROR 1150 RETURNED. THE CUSTOMER CONFIRMED THE SAME ISSUE. THE TSE ADVISED THE CUSTOMER TO SWITCH OFF THE DEFECTIVE SURGEON SIDE CONSOLE (SSC) 65153 AND CONTINUE WITH THE SURGERY USING ONE SSC. TSE FOUND ERROR 83 TWO TIMES AND BOTH FOR SURGEON HEAD SENSOR (SHS) SN MISMATCH SSC2. BOTH ERRORS WERE PRECEDED BY ERROR 1150, POINTING TO COMMUNICATION ISSUE WITH SSC2 SHS. THEREFORE ERROR 83 WAS CONSIDERED TO BE TRAIN WRECK OF ERROR 1150. THE PROCEDURE WAS COMPLETED AS PLANNED WITH ONE SSC WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804238 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-16 NA 00886874110744

    Patients

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