BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 12021830 · Received June 17, 2021

    Report

    Report Number
    2955842-2021-10671
    Event Type
    Death
    Date Received
    June 17, 2021
    Date of Event
    February 26, 2021
    Report Date
    May 24, 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
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION REMAINS UNKNOWN. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION RELATED TO THIS COMPLAINT IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS FOR THE PROCEDURE DATE OF (B)(6) 2021 HAS BEEN PERFORMED. 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 LOG REVIEW SUPPORTS THE CUSTOMER CLAIM THAT THERE WAS NO PRODUCT ISSUE DURING THE CASE. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: CADIERE FORCEPS, AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. THE LOGS WERE REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS ENGINEER (FAE) AND THERE WERE NO ERRORS OF ANY KIND RECORDED DURING THE PROCEDURE. THERE WAS ALSO NO USAGE PATTERNS THAT STOOD OUT. THE LOGS WERE NORMAL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A MEDICAL REVIEW BY PERFORMED BY AN ISI MEDICAL SAFETY OFFICER, AND THE FOLLOWING FINDINGS WERE OBSERVED: "MEDIAN ARCUATE LIGAMENT SYNDROME (MALS) IS A CONDITION IN WHICH THE MEDIAN ARCUATE LIGAMENT PRESSES TOO TIGHTLY ON THE CELIAC ARTERY (A MAJOR BRANCH OFF THE AORTA THAT DELIVERS BLOOD TO THE STOMACH, LIVER, AND OTHER ORGANS) AND THE NERVES OF THE CELIAC PLEXUS. THE LOCATION OF THE THORACIC DUCT SITS JUST MEDIAL TO THE ORIGIN OF THE CELIAC TRUNK. INJURY TO THE THORACIC DUCT LEADS TO CHYLOUS ASCITES. CHYLOUS ACITES ARE A KNOWN POST-OPERATIVE COMPLICATION AFTER MALS SURGERY GIVEN THE CLOSE PROXIMITY OF THE THORACIC DUCT TO THE CELIAC ARTERY. HOWEVER, THE MOST COMMON COMPLICATIONS OF MALS SURGERY ARE BLEEDING, PNEUMOTHORAX. THE CAUSE OF THE INJURY TO THE THORACIC DUCT IS UNKNOWN BUT IS LIKELY TO HAVE OCCURRED DURING THE DIVISION OF THE MEDIAN ARCUATE LIGAMENT IN THE LOCATION OF CISTERNA CHYLI. TYPICAL TREATMENT INCLUDES BOWEL REST, TPN, OCTREOTIDE AND DRAINAGE. IF A PATIENT FAILS NON-OPERATIVE TREATMENT, PATIENTS MAY BE OFFERED SURGICAL LIGATION OF THE THORACIC DUCT. THE PATIENT¿S STROKE OCCURRED AFTER THE INJECTION OF POPPY SEED OIL. IT IS UNKNOWN AS TO THE LOCATION OF THE INJECTION OF THE POPPY SEED OIL. HOWEVER, BASED UPON THE INFORMATION PROVIDED, IT SEEMS REASONABLE TO CONCLUDE THAT THE INJECTION IS THE MOST LIKELY CAUSE OF THE PATIENT¿S STROKE." THIS COMPLAINT IS A REPORTABLE ADVERSE EVENT DUE TO THE FOLLOWING: AFTER A DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME (MALS) PROCEDURE, THE PATIENT DEVELOPED CHYLE LEAK ON POST-OP DAY (POD) 15. THE PATIENT WAS INITIALLY PUT ON CONSERVATIVE MANAGEMENT TO MANAGE THE CHYLE LEAK BUT DID NOT RESPOND. SHE SUBSEQUENTLY UNDERWENT AN INTERVENTIONAL RADIOLOGY PROCEDURE WHEREBY POPPYSEED OIL WAS INJECTED TO STOP THE LEAK ON POD 28 AND IMMEDIATELY SUFFERED A STROKE. THE PATIENT PASSED AWAY ON POD 32. THE SYSTEM LOG REVIEW DID NOT SHOW ANY EVENTS THAT WOULD SUGGEST A PRODUCT ISSUE. AN ADVANCED FAILURE ANALYSIS (AFA) ENGINEER REVIEWED THE VESSEL SEALER LOGS AND DID NOT FIND ANY ERRORS. THERE IS NO INSTRUMENT EXPECTED TO BE RETURNED AS THERE WAS NO ALLEGATION OF AN INSTRUMENT MALFUNCTION. THE SURGEON CONFIRMED THAT THERE WAS NO THORACIC DUCT INJURY DURING THE PROCEDURE, AND THE REASON OF THE CHYLE LEAK WAS UNKNOWN, ALTHOUGH IT TYPICALLY HAPPENS WITH DISSECTION AND TISSUE DIVISION. PREMORBIDLY, THE PATIENT SUFFERED FROM CHRONIC MALNUTRITION, WHICH WOULD PUT HER AT A HIGHER RISK FOR SURGICAL COMPLICATIONS AND A POORER ABILITY TO RECOVER FROM ANY COMPLICATIONS THAT OCCURRED. THE CAUSE OF DEATH ON THE AUTOPSY REPORT WAS STROKE AND THE SURGEON ATTRIBUTED THE CAUSE OF DEATH TO STROKE SECONDARY TO THE INTERVENTION RADIOLOGY PROCEDURE. THERE WAS NO ALLEGATION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTION DURING THE PROCEDURE AND NO ALLEGATION THAT THE DA VINCI SYSTEM CONTRIBUTED TO PATIENT HARM, INJURY, OR THE PATIENTS¿ DEATH. THE INSTRUMENTS WORKED AS EXPECTED, THERE WAS NO UNINTUITIVE MOTION OF THE SYSTEM ARMS OR INSTRUMENTS, AS WELL AS NO SYSTEM ERRORS GENERATED DURING THE MALS PROCEDURE. HOWEVER, AS THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION IS UNKNOWN, THIS EVENT IS BEING REPORTED AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    AFTER A DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME (MALS) PROCEDURE, THE PATIENT DEVELOPED A CHYLE LEAK AND PASSED AWAY AT AN UNSPECIFIED DATE AFTER THE PROCEDURE. IT IS UNKNOWN IF THERE WERE ANY ISSUES THAT OCCURRED DURING THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI KEY ACCOUNT MANAGER AND OBTAINED THE FOLLOWING INFORMATION: HE WAS INFORMED ABOUT THE INCIDENT BY ANOTHER SURGEON. THERE WAS NO KNOWN INTRAOPERATIVE COMPLICATION, ARCING, MALFUNCTION OF INSTRUMENT, SYSTEM ERRORS OR INJURY TO THE SURROUNDING STRUCTURES DURING THE PROCEDURE. THE PROCEDURE WAS DESCRIBED AS "COMPLETED WELL". THE PATIENT DEVELOPED A CHYLE LEAK AFTER THE PROCEDURE ON AN UNSPECIFIED DATE AND DIED ON AN UNSPECIFIED DATE. IT WAS UNKNOWN WHAT THE CAUSE OF DEATH ON THE DEATH CERTIFICATE/AUTOPSY REPORT WAS. PATIENT DEMOGRAPHIC INFORMATION/PREEXISTING MEDICAL ILLNESS/RELEVANT INVESTIGATION WAS ASKED BUT WAS UNKNOWN. ISI FOLLOWED UP WITH SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE MALS PROCEDURE COMPLETED SUCCESSFULLY ROBOTICALLY AND THERE WERE NO OBSERVED INTRAOPERATIVE COMPLICATIONS. THERE WERE NO ISSUES WITH THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES USED. NO ERRORS OCCURRED WITH THE VESSEL SEALER INSTRUMENT, AND THE APPROPRIATE TONES WERE PRODUCED. THERE WAS NO INSTRUMENT ARCING, NO UNINTUITIVE MOTION OF THE INSTRUMENTS NOR ANY SYSTEM ERRORS OBSERVED. THE SURGEON DENIED ANY THORACIC DUCT INJURY. POST-OPERATIVELY, THE PATIENT DEVELOPED A CHYLE LEAK, ABDOMINAL PAIN AND ABDOMINAL DISTENSION ON (B)(6) 2021. THE CAUSE OF THE CHYLE LEAK WAS UNKNOWN BUT IT WAS NOTED THAT IT TYPICALLY HAPPENS WITH DISSECTION AND TISSUE DIVISION. THE PATIENT WAS PLACED ON A NO-FAT DIET, BUT IT WAS UNSUCCESSFUL. ON (B)(6) 2021, THE PATIENT WAS ADMITTED FOR TOTAL PARENTERAL NUTRITION (TPN). ON (B)(6) 2021, SHE UNDERWENT AN INTERVENTIONAL RADIOLOGY PROCEDURE TO INJECT POPPYSEED OIL TO STOP LYMPHATIC SYSTEM LEAKS. IMMEDIATELY FOLLOWING THIS PROCEDURE, THE PATIENT SUFFERED A STROKE. THE PATIENT WAS PLACED ON COMFORT MEASURES AND PASSED AWAY ON (B)(6) 2021. THE CAUSE OF DEATH WAS DUE TO STROKE. THE SURGEON BELIEVES THAT THE CAUSE OF DEATH WAS RELATED TO THE INTERVENTIONAL RADIOLOGY PROCEDURE. NO IMAGES/VIDEO ARE AVAILABLE FOR ISI REVIEW. THE PATIENT SUFFERED FROM 50+YEARS OF CHRONIC MALNUTRITION DUE TO CELIAC ARTERY COMPRESSION DUE TO MALS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911528 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR