BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 14325770 · Received May 7, 2022

    Report

    Report Number
    2955842-2022-11460
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE INSTRUMENT LOGS WAS PERFORMED FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM (B)(4). THERE WERE FOUR INSTRUMENTS RECORDED FOR THIS PROCEDURE, THREE OF WHICH WERE RECORDED AS BEING USED DURING THIS PROCEDURE. 8MM 30 DEGREE ENDOSCOPE (PART #470027-65; LOT #0000903-289; SERIAL (B)(4)) HAD 1977 OF 2000 USES REMAINING AND WAS RECORDED AS BEING USED FOR 19 SECONDS IN THIS PROCEDURE. FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT (PART #471205-17; LOT #N14200615-0080; SERIAL (B)(4)) HAD 13 OF 14 USES REMAINING AND WAS RECORDED AS BEING USED FOR 54 SECONDS IN THIS PROCEDURE. PERMANENT CAUTERY HOOK (PCH) INSTRUMENT (PART #470183-14; LOT #N11200727-0032; SERIAL (B)(4)) HAD 9 OF 10 USES REMAINING AND WAS NOT RECORDED AS BEING USED FOR THIS PROCEDURE. SINGLE USE SUCTION IRRIGATOR (PART #480299-06; LOT #M10200510-0218; SERIAL (B)(4)) HAD 0 OF 1 USES REMAINING AND WAS RECORDED AS BEING USED FOR 49 SECONDS IN THIS PROCEDURE. WHILE ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE NOT BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THE INSTRUMENTS. THE MAXIMUM AMOUNT OF TIME THAT ANY INSTRUMENT WAS IN USE WAS 54 SECONDS. TROCARS ARE ACCESSORIES AND ARE NOT RECORDED IN SYSTEM LOGS. A SYSTEM ERROR LOG REVIEW WAS ALSO CONDUCTED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE LOGS SHOWED THAT THE PROCEDURE STARTED AND THE SURGEON WENT INTO FOLLOWING MODE APPROXIMATELY 3 MINUTES THEREAFTER. WHILE THE END OF PROCEDURE WAS RECORDED AT 212 MINUTES (3.5 HOURS) LATER, INSTRUMENTS SHOW IN USE FOR ONLY A MAXIMUM OF 54 SECONDS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A MEDICAL REVIEW FROM AN ISI MEDICAL SAFETY OFFICER WAS COMPLETED AND RESULTS WERE AS FOLLOWS: BASED UPON THE INFORMATION IN THE DESCRIPTION OF THE EVENT, THE PATIENT¿S AORTA WAS INJURED DURING THE INITIAL PLACEMENT OF A THIRD-PARTY TROCAR RESULTING IN ACUTE BLOOD LOSS ANEMIA, LEADING TO HYPOPERFUSION AND SUBSEQUENT DEATH. THERE IS A CLEAR INDICATION FROM THE SITE THAT THE INJURY TO THE AORTA WAS CAUSED DURING THE INITIAL PLACEMENT OF THE THIRD-PARTY TROCAR. ADDITIONALLY, THE INFORMATION FROM THE SYSTEM LOGS WOULD INDICATE THAT BLEEDING WAS PRESENT WITHIN THE ABDOMEN PRIOR TO THE SURGEON STARTING THE ROBOTIC PORTION OF THE OPERATIVE PROCEDURE. THE DA VINCI SURGICAL SYSTEM, INSTRUMENTATION, AND ACCESSORIES WERE ONLY IN USE FOR A TOTAL OF 54 SECONDS. A SUCTION IRRIGATOR WAS USED IN 49 OF THOSE 54 SECONDS. IT IS HIGHLY IRREGULAR TO REQUIRE THE USE OF A SUCTION IRRIGATOR AT THE START OF ANY CASE, LET ALONE A VENTRAL HERNIA REPAIR. THE SUCTION IRRIGATOR WAS MOST LIKELY REQUIRED BY THE SURGEON OF RECORD TO HELP IDENTIFY THE SOURCE OF BLEEDING THAT OCCURRED FROM AN INJURY SUSTAINED TO THE AORTA FROM THE THIRD-PARTY TROCAR PRIOR TO EVEN DOCKING THE DA VINCI SYSTEM. THE DA VINCI SYSTEM, INSTRUMENTATION, AND ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE INJURY SUSTAINED TO THE PATIENT¿S AORTA WHEN THE SURGEON PLACED A THIRD-PARTY TROCAR CAUSING ACUTE BLOOD LOSS ANEMIA, HYPOPERFUSION, AND DEATH. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPIRED DUE TO ACUTE BLOOD LOSS ANEMIA AND HYPOPERFUSION DUE TO AN AORTIC INJURY RESULTING FROM THE SURGEON PLACING A TROCAR. WHILE IT WAS REPORTED THAT THE LOCATION OF THE BLEEDING WAS AT THE LOCATION WHERE THE INITIAL TROCAR (A THIRD-PARTY MANUFACTURER PRODUCT) PLACEMENT WAS ATTEMPTED, IT IS UNKNOWN TO WHAT DEGREE THE DA VINCI SYSTEM, INSTRUMENTS, AND ACCESSORIES USED DURING THIS PROCEDURE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE SURGEON WAS ¿OPTI-VIEWING WITH A TROCAR AND IT KEPT SHOWING OCCLUSION; THERE WAS A LITTLE BIT OF BLOOD BUT WASN'T MUCH.¿ THE SURGEON ¿PLACED THE TROCAR IN A DIFFERENT LOCATION DUE TO THE OCCLUSION AND FINISHED PLACING PORTS AND DOCKED ROBOT.¿ THE PATIENT'S BLOOD PRESSURE DROPPED SEVERELY AND THE SYSTEM WAS UNDOCKED. IT WAS REPORTED THAT THE SURGEON HAD HIT THE AORTA WITH THE TROCAR WHEN ORIGINALLY TRYING TO PLACE IT. THE CASE STARTED AT 10:00 AM AND PATIENT EXPIRED AROUND 2:00 PM. A COUPLE OF OTHER SURGEONS CAME IN THE ROOM TO TRY TO HELP REVIVE PATIENT AND WERE UNSUCCESSFUL. THE PATIENT SUBSEQUENTLY EXPIRED. ON 25-FEB-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, A (B)(6) FEMALE PATIENT EXPIRED POST PLACEMENT OF A TROCAR WHICH ALLEGEDLY CAUSED A LACERATION TO THE AORTA AND RESULTED IN EXCESSIVE BLEEDING. IT WAS REPORTED THAT AS THE SURGEON WAS ATTEMPTING TO INSERT AN ¿OPTIVIEW 5MM TROCAR" BY ¿APPLIED MEDICAL¿ WITH A 5MM "STRYKER SCOPE,¿ THE SURGEON ¿MET WITH AN OCCLUSION.¿ IT WAS REPORTED THAT, INSTEAD OF PLACING IT ON THE SIDE, THE SURGEON WENT FOR INGUINAL PLACEMENT ABOVE THE BELLY BUTTON. DUE TO THE OCCLUSION, THE SURGEON WENT TO THE OTHER SIDE AND GOT IN. THERE WAS AN UNSPECIFIED SMALL AMOUNT OF BLOOD OBSERVED AT AN UNKNOWN LOCATION AND PORT PLACEMENT AND SYSTEM DOCKING WAS COMPLETED. JUST AS THE SYSTEM DOCKED, THE PATIENT'S BLOOD PRESSURE DROPPED SEVERELY AND THE SYSTEM WAS UNDOCKED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WHERE IT WAS OBSERVED THAT THE AORTA HAD BEEN DAMAGED; THE AORTA WAS PUNCTURED AT THE POINT WHERE THE INITIAL TROCAR PLACEMENT HAD BEEN ATTEMPTED. THERE WAS BLOOD LOSS OF ¿WELL OVER 750 ML¿ AND AN UNSPECIFIED AMOUNT OF BLOOD TRANSFUSION WAS ADMINISTERED. CONSULTING SURGEONS ATTEMPTED TO ASSIST WITH THE EVENT. IT WAS REPORTED THAT THE SITE ¿TRIED EVERYTHING THEY COULD¿; WORKING ON THE PATIENT FROM 10:00 AM TO 2:00 PM YET SPECIFIC ATTEMPTED MEDICAL INTERVENTION AND SPECIFIC ADDITIONAL COMPLICATIONS WERE UNKNOWN. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068682 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES