BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 12601856 · Received October 8, 2021

    Report

    Report Number
    2955842-2021-11264
    Event Type
    Death
    Date Received
    October 8, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 13, 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
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: A2, A3, A4, B7, G6, H2, AND H10. ON (B)(6) 2021, INTUITIVE SURGICAL INC. (ISI) RECEIVED MW 2200710000-2021-8038 STATING: ¿THE PATIENT IS AN ELDERLY WOMAN WHO HAD A HISTORY OF HAVING A LEFT UPPER LOBE TRISEGMENTECTOMY. SHE HAD DONE WELL HOWEVER 4 MONTHS LATER DEVELOPED A BRONCHOPLEURAL FISTULA. THERE WAS A SMALL OPENING IN THE BRONCHUS OF THE UPPER DIVISION OF THE LEFT UPPER LOBE BRONCHUS. THE SPACE WAS CONTROLLED WITH A DRAIN THAT WAS PLACED PERCUTANEOUSLY AND ANTIBIOTICS. HOWEVER, SHE HAD A PERSISTENT SPACE AND AIR LEAK. THREE MONTHS AGO, THE PATIENT WAS BROUGHT TO THE OR FOR EXPLORATORY THORACOTOMY USING THE DAVINCI XI ROBOTIC SURGICAL TECHNOLOGY. THE PATIENT WAS POSITIONED/PLACED IN A RIGHT LATERAL DECUBITUS POSITION WITH THE LEFT SIDE UP AND PREPPED AND DRAPED IN A STERILE FASHION. THE SURGEON MADE AN 8 MM INCISION AT THE EIGHTH INTERCOSTAL SPACE POSTERIOR AXILLARY INTO THE CHEST CAVITY THERE WERE ADHESIONS THAT WERE TAKEN DOWN SHARPLY, THE SURGEON THEN PLACED THE REST OF THE PORTS AND DOCKED THE ROBOT. THE SURGEON MOBILIZED THE LUNG IN ITS ENTIRETY AGAIN AS THERE WERE DENSE ADHESIONS, ESPECIALLY TO THE ANTERIOR MEDIASTINUM. THE SURGEON NOTED THEY WERE ABLE TO MOBILIZE THE LUNG AND DISSECT ONTO THE AREA OF CONCERN. THE SURGEON IDENTIFIED THE SUPER LINGULAR BRANCH OF THE PULMONARY VEIN, THE BRONCHIAL STUMP, AND THE LEFT MAIN PULMONARY ARTERY. THE SURGEON DISSECTED THE BRONCHUS OFF OF THE LEFT MAIN PULMONARY ARTERY HOWEVER DURING THAT MANEUVER THERE WAS IMMEDIATE BLEEDING FROM THE LEFT MAIN PULMONARY ARTERY. AT THAT TIME THE SURGICAL TEAM ATTEMPTED TO GAIN BY PLACING A SPONGE ONTO THE PULMONARY ARTERY AS WELL AS COMPRESSING WITH THE LUNG. THE SURGICAL TEAM QUICKLY CONVERTED TO A POSTERIOR LATERAL THORACOTOMY AND UNDOCKED THE ROBOT AND TRY TO MANUALLY GAIN CONTROL OF THE BLEEDING. THE PATIENT HAD IMMEDIATELY LOST HER BLOOD PRESSURE AND WENT PULSELESS. DESPITE OUR HAVING CONTROL AND RESUSCITATION, THE PATIENT DID NOT REGAIN A MEANINGFUL PULSE DESPITE AN ATTEMPT AT INTRAPERICARDIAL MASSAGE AND SHE WAS PRONOUNCED DEAD IN THE OPERATING ROOM.¿ THE CUSTOMER ALSO STATED: "THE SURGICAL QA CHAIR REVIEW OF THIS SURGICAL CASE--THERE WAS NOT ANY DEVICE ISSUE BUT POOR PATIENT MEDICAL CONDITION."

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY COMPLAINT REVIEW WAS CONDUCTED ON 16-SEP-2021 AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM ERROR LOG REVIEW WAS CONDUCTED ON 16-SEP-2021 FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM (B)(4). 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. A REVIEW OF THE INSTRUMENT LOGS WAS ALSO PERFORMED. CADIERE FORCEPS (PART # 471049-07; LOT # N10201207-0127; SERIAL #:(B)(4) WAS IN USE FOR 1:40:49 (1 HOUR, 40 MINUTES, 49 SECONDS) WITH NO VISIBLE EVENTS IN THE LOGS SPECIFIC TO THIS INSTRUMENT. WHILE NOT ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THE INSTRUMENTS. AN ISI ADVANCED FAILURE ANALYST (AFA) ENGINEER CONDUCTED A SYSTEM LOG REVIEW AND THE FINDINGS WERE AS FOLLOWS: ALL OF THE ERRORS IN THE LOGS FOR THAT PROCEDURE WERE NO FAULT REACTION ENTRIES FOR THE TRUMPF TABLE; SO NONE OF THESE WOULD SUGGEST A PRODUCT ISSUE. ENTRIES 32, 98, AND 81 ARE THE NODEID AND WERE NOT ERRORS IN THIS CASE. 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. AN ISI MEDICAL SAFETY OFFICER (MSO) CONDUCTED FILE MEDICAL REVIEW AND RESULTS WERE AS FOLLOWS: BASED UPON THE INFORMATION IN THE DESCRIPTION OF EVENTS THE PATIENT UNDERWENT AN ATTEMPTED REPAIR OF A BRONCHOPLEURAL FISTULA. IT IS NOT CLEAR AS TO THE ETIOLOGY OF THE PATIENT'S UNDERLYING MEDICAL CONDITION. DURING THE PROCEDURE, THE PULMONARY ARTERY BURST WHILE THE SURGEON WAS ATTEMPTING TO LIFT VESSEL USING A CADIERE FORCEPS. THE SURGEON INDICATED THAT REASON THAT THE PULMONARY ARTERY BURST WAS DUE TO GENERAL CONDITION OF THE PULMONARY ARTERY, WHICH WAS NOTED TO BE "FRIABLE." ADDITIONALLY, THE SURGEON OF RECORD, WITH MORE THAN 960 COMPLETED ROBOTIC PROCEDURES, INDICATED THAT THE ANATOMY WAS STRANGE AND ABNORMAL MAKING VISUALIZATION DIFFICULT. THE SURGEON INDICATED THAT BLEEDING FROM THE PULMONARY ARTERY WAS CAUSED BY THE LIFTING OF THE FRAGILE PULMONARY ARTERY WITH THE CADIERE FORCEPS INSTRUMENT. ACCORDING TO THE INFORMATION PROVIDED BY THE SURGEON, IT SEEMS PLAUSIBLE THAT THE CAUSE OF THE BLEEDING FROM THE PULMONARY ARTERY THAT LED TO THE EMERGENT CONVERSION TO AN OPEN PROCEDURE AND ULTIMATELY THE PATIENTS DEATH CAN BEST BE ATTRIBUTED FROM THE PATIENTS UNDERLYING MEDICAL CONDITIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE IT WAS REPORTED THE SURGEON WAS USING A CADIERE FORCEPS INSTRUMENT WHEN THE PULMONARY ARTERY (PA) VESSEL BURST, CAUSING BLEEDING, THERE IS NO ALLEGATION OR EVIDENCE OF A PRODUCT FAILURE THAT WOULD BE CLASSIFIED AS A MALFUNCTION. THE DESCRIBED EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT AS THERE WAS A REPORT OF A VESSEL INJURY RESULTING IN AN UNSPECIFIED AMOUNT OF BLEEDING FOR WHICH THE DA VINCI PROCEDURE CONVERTED TO OPEN SURGERY AND THE PATIENT EXPIRED. ADDITIONAL EVENT DETAILS WERE UNKNOWN. AT THIS TIME, THE ROOT CAUSE OF THE ISSUE AND THE PATIENTS DEATH ARE UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 1

    AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), VIA AN INITIAL REPORT FROM A FELLOW/RESIDENT WHO WAS IN THE OPERATING ROOM (OR) AT THE TIME OF THE EVENT, THEN AN UNSPECIFIED SITE NURSE WHO WAS NOT IN THE OPERATING ROOM AT THE TIME OF THE EVENT, CONTACTED AN ISI CUSTOMER SERVICE REPRESENTATIVE TO INITIALLY REPORT THAT DURING A DA VINCI-ASSISTED BRONCHOPLEURAL FISTULA PROCEDURE ON (B)(6) 2021, THE PATIENT'S ANATOMY WAS "STRANGE/NOT NORMAL" AND VISIBILITY WAS DIFFICULT. THE SURGEON NICKED THE PATIENT'S PULMONARY ARTERY WHICH CAUSED THEM TO CONVERT TO OPEN SURGERY DUE TO BLEEDING. WHILE IN OPEN SURGERY, THE PATIENT PASSED AWAY ON (B)(6) 2021. THE INITIAL REPORT SOURCE RECORD INDICATED THAT THE SURGEON/SITE DOES NOT BELIEVE THAT THE INTUITIVE DEVICE(S) CAUSED OR CONTRIBUTED TO THE REPORTED INJURY OR DEATH. ON 17-SEP-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON DIRECTLY: DURING A DA VINCI-ASSISTED ATTEMPTED REPAIR OF A BRONCHOPLEURAL FISTULA ON (B)(6) 2021, AS THE SURGEON WAS 80% - 90% THROUGH THE PROCEDURE THE SURGEON WAS USING A CADIERE FORCEPS INSTRUMENT TO LIFT UP THE PA [PULMONARY ARTERY], AND THE PA VESSEL BURST AND STARTED BLEEDING. THE SURGEON SAID THAT THE VESSEL COULD HAVE BURST ON ITS OWN EVEN WITHOUT MANEUVERING IT BECAUSE THE VESSEL WAS SO FRIABLE. IT WAS REPORTED THAT THE SURGEON IS NOT BLAMING THE ROBOT, IT WAS AN ISSUE WITH THE PATIENT'S ANATOMY BEING STRANGE AND NOT NORMAL," MAKING VISIBILITY DIFFICULT. IT WAS REPORTED THAT THE SURGEON KNEW ALL THAT GOING IN AND KNEW THAT THE PATIENT WAS VERY SICK. DUE TO THE PA ARTERY BLEEDING, THE PROCEDURE CONVERTED TO OPEN SURGERY. WHILE IN THE OPEN SURGERY, THE PATIENT EXPIRED ON (B)(6) 2021. IT WAS REPORTED THAT THE FAMILY ALLEGEDLY DID NOT SEEM SHOCKED THAT THE PATIENT HAD EXPIRED. ADDITIONAL DETAIL FROM THE SURGEON WAS REQUESTED BUT WAS NOT PROVIDED. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION FROM THE SURGEON WERE HALTED DUE TO THE FOLLOW-UP CALL WITH THE SURGEON ABRUPTLY ENDING AND THE FOLLOWING INFORMATION WAS NOT DISCLOSED: WHAT WAS STRANGE ABOUT THE ANATOMY? ANYTHING IN THE PATIENT'S HISTORY THAT WOULD CAUSE STRANGE ANATOMY? WHAT OTHER INSTRUMENTS WERE USED AT THE TIME OF THE INJURY? ANY RETRACTION ISSUE? HOW BIG OF AN INJURY TO THE VESSEL? DID YOU TRY TO ADDRESS IT AND IT TORE MORE? WHAT MEDICAL INTERVENTION WAS ATTEMPTED? WHAT OTHER LIFE SAVING MEASURES WERE TAKEN? //PATIENT AGE, DOB, GENDER, WEIGHT, ETHNICITY, RACE, RELEVANT PATIENT TESTS AND LABS & RESULTS WITH DATE(S) PERFORMED, ADDITIONAL RELEVANT PATIENT HISTORY, INCLUDING PRE-EXISTING MEDICAL CONDITIONS, WHAT OTHER INTRA-OPERATIVE COMPLICATIONS, IF ANY, DID THE PATIENT EXPERIENCE? WHAT IS THE CAUSE OF DEATH AS IT APPEARS ON THE DEATH CERTIFICATE/AUTOPSY REPORT/DISCHARGE SUMMARY? WHAT WAS THE AMOUNT OF BLOOD LOSS? WERE ANY BLOOD TRANSFUSIONS ADMINISTERED; IF SO WHAT WAS THE AMOUNT OF BLOOD TRANSFUSED? WHAT WAS THE CAUSE OF THE PATIENT'S UNDERLYING BRONCHOPLEURAL FISTULA?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498746 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES