BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16380497 · Received February 15, 2023

    Report

    Report Number
    2955842-2023-10688
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 18, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. AN ISI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE, REVIEWED ERROR LOGS, AND VERIFIED SYSTEM TO BE READY FOR USE. ALTHOUGH THE FSE WAS UNABLE TO REPLICATE OR REPRODUCE THE CUSTOMER REPORTED MANIPULATOR ISSUE, THE PATIENT SIDE CART (PSC) CARD CAGE WAS REPLACED. THE FAILURE ANALYSIS OF THE CARD CAGE IS STILL UPENDING. ISI HAS RECEIVED THE 0 DEGREE ENDOSCOPE PLUS ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF A ¿BAD SOUND¿ AND NOTED THE FOLLOWING ISSUES: DAMAGED/FRICTION ISSUE, DAMAGED CABLE INTEGRITY, AND DISCOLORATION OF HOUSING. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AN ADVANCED INSTRUMENT LOG REVIEW ON THE MCS INSTRUMENT WAS PERFORMED FOR THIS PROCEDURE BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, IT APPEARS THAT THERE IS A POTENTIALLY RELATED ERROR TO THE REPORTED COMPLAINT WHICH STATES ¿A SURGEON¿S HAND MAY NOT HAVE BEEN TOUCHING THE RIGHT MTM WHILE IN FOLLOWING MODE AT SSC1¿ (SURGEON SIDE CONSOLE). THIS INDICATES THAT THE SYSTEM HAS DETECTED CONDITIONS CONSISTENT WITH THE MASTER TOOL MANIPULATOR (MTM) MOVING IN FOLLOWING WITHOUT THE SURGEON¿S HANDS ON THE HANDLE. AN ADVANCED LOG REVIEW ON THE USMS WAS PERFORMED FOR THIS PROCEDURE BY AN ISI ADVANCED FAE. PER THE FAE, THERE IS NOTHING IN THE LOGS THAT WOULD SUGGEST ANYTHING WRONG WITH THE SYSTEM THAT MAY HAVE CAUSED THE NON-INTUITIVE MOTION. THERE WERE NO ERRORS ON ARM [USM] 4, THE ARM THAT THE MCS INSTRUMENT WAS INSTALLED ON. THE ENDOSCOPE WAS INSTALLED ON ARM 3 WHICH DID HAVE A FEW ENGAGEMENT FAILURES. THIS ARM HAS NOT EXPERIENCED ANY ENGAGEMENT ERRORS SINCE THAT PROCEDURE, SO IT WAS LIKELY A SEATING ISSUE OR SOMETHING WRONG WITH THE ENDOSCOPE CAUSING THE ENGAGEMENT FAILURES. TO BE CLEAR, AN ENGAGEMENT FAILURE DOES NOT CONFIRM THE NON-INTUITIVE MOTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT¿S VAS DEFERENS WAS INJURED. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. NOTE: REFER TO THE MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE REPORTED EVENT LOGGED AGAINST THE 0 DEGREE ENDOSCOPE. NOTE: REFER TO THE MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE REPORTED EVENT LOGGED AGAINST THE MCS INSTRUMENT. NOTE: REFER TO THE MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE REPORTED EVENT LOGGED AGAINST THE 0 DEGREE ENDOSCOPE.

    Additional Manufacturer Narrative · 0

    ON 21-FEB-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE PATIENT SIDE CART CARD CAGE: FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE CARD CAGE WAS INSTALLED AND TESTED ON THE PCA [PRINTED CIRCUIT ASSEMBLY] TEST SYSTEM. THE SYSTEM STARTED UP WITHOUT ANY ERROR, WITH GOOD IMAGE, AND GOOD AUDIO. ALL THE GANTRY MOTORS WERE DRIVEN THE FULL RANGE OF MOTION WITHOUT ANY ERROR. ALL ARMS [UNIVERSAL SURGICAL MANIPULATORS] MOVED INTUITIVELY. 50X POWER CYCLES WERE RAN WITH THIS PART AND ALL PASSED. THE CARD CAGE REMAINED ON THE TEST SYSTEM FOR 8 IN NORMAL OPERATION; WHILE TESTING OTHER BOARDS, IT PERFORMED WITHOUT ANY ISSUE. NO ARM [USM] MOVED SUDDENLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT SIDE CART (PSC) EXPERIENCED NON-INTUITIVE MOTION WHILE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS IN USE IN UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE ISSUE OCCURRED DURING THE END OF THE PROCEDURE WHILE PERFORMING THE ANASTOMOSIS. THE SURGEON ROTATED THE 0 DEGREE ENDOSCOPE PLUS SEVERAL TIMES WHILE LOOKING FOR A SUTURE NEEDLE AFTER WHICH THE MCS ¿WENT OUT OF CONTROL¿ TOWARDS THE VAS DEFERENS AND UNINTENTIONALLY TRANSECTED IT. THE ARTERY AND VEIN NEXT TO THE VAS DEFERENS DID NOT CONTACT THE MCS AND WERE NOT INJURED, ALTHOUGH THE SURGEON FEARED AT THE TIME THAT THIS COULD OCCUR AS HE DID NOT HAVE CONTROL OF THE MCS. WHILE ROTATING THE ENDOSCOPE, A ¿BAD SOUND¿ WAS HEARD. NO ERROR MESSAGE WAS DISPLAYED. ALL THE INSTRUMENTS WERE THEN REMOVED FROM THEIR RESPECTIVE USMS AND REINSTALLED, AND THE SURGEON CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN 8MM 30 DEGREE ENDOSCOPE. THE SURGEON BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS DUE TO A PROBLEM WITH THE 0 DEGREE ENDOSCOPE PLUS FOLLOWED BY "BAD MOVEMENTS" WITH THE USMS. THE TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE SYSTEM ERROR LOGS AND FOUND NO RELEVANT ERRORS. THE PATIENT DID NOT EXPERIENCE AND POST-OPERATIVE COMPLICATIONS AND WAS REPORTED TO BE DOING FINE.

    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
    1291033 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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