BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 20233782 · Received September 16, 2024

    Report

    Report Number
    2955842-2024-19536
    Event Type
    Death
    Date Received
    September 16, 2024
    Date of Event
    August 19, 2024
    Report Date
    August 19, 2024
    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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A VIDEO OF THE EVENT WAS PROVIDED BY THE CUSTOMER AND REVIEW SHOWED THE SURGEON WAS DISSECTING AND TRYING TO GO AROUND A BRANCH OF THE PA WHEN THE INJURED AREA STARTED TO OOZE. THE SURGICAL INSTRUMENT WAS MOVED AWAY FROM THE PA AND LATER REPOSITIONED IN SUCH A WAY THAT IT APPEARS TO PUSH DOWN ON THE MAIN BRANCH OF THE ARTERY, CAUSING THE MAJOR BLEEDING EVENT. THE ENDOSCOPE WAS REMOVED, CLEANED, AND REINSTALLED. THE ROBOT UNIVERSAL SURGICAL MANIPULATOR (USM 2), WHICH WAS HOUSING THE ENDOSCOPE, DISPLAYED A USER FACING MESSAGE SAYING, ¿ADVANCE ENDOSCOPE TO EARLIER POSITION¿. HOWEVER, THE BLEEDING FROM THE PA WAS OBSCURING THE VIEW OF THE SURGICAL WORKSPACE. THE ENDOSCOPE WAS REMOVED AGAIN AND REINSTALLED BACK ONTO USM 2 WHEN ¿ADVANCE ENDOSCOPE TO EARLIER POSITION¿ AND ¿DISENGAGEMENT OF THE ARM AT THE PSM¿ MESSAGING APPEARS. A SUCTION INSTRUMENT IS SEEN TRYING TO SUCTION THE BLOOD FROM THE SITE, FOLLOWED BY REMOVAL OF THE OTHER INSTRUMENTS AND ACCESSORIES, THEN REMOVAL OF THE SUCTION AND THE ENDOSCOPE. THE ACTIONS NOTED ABOVE OCCURRED OVER THE COURSE OF APPROXIMATELY TWO MINUTES. REVIEW OF THE DVSTREAM LOG AND KINEMATIC DATA SHOWED ENDOSCOPE REMOVAL, FOLLOWED BY RE-INSTALLATION. APPROXIMATELY 8 SECONDS LATER THE ENDOSCOPE WAS REMOVED AND REINSTALLED AGAIN, FOLLOWED BY A SHORT PERIOD OF ENDOSCOPE CONTROL ACTIVATION, THEN ENDOSCOPE REMOVAL WITHIN APPROXIMATELY 10 SECONDS. REVIEW OF THE SYSTEM LOGS FOUND THERE WERE NO ERRORS RELATED TO THE REPORTED PULMONARY ARTERY INJURY EVENT. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM FOUND NO ERRORS OCCURRED THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) USED FOUND THERE WERE NO NON-CONFORMANCES IDENTIFIED TO BE RELATED TO THIS EVENT. VIDEO REVIEW COINCIDES WITH AN ENDOSCOPE THAT LOST ITS CONNECTION TO THE STERILE ADAPTER, PROMPTING THE USER WITH THE ¿ARM NOT READY. REMOVE THE ENDOSCOPE TO CONTINUE¿ MESSAGE. THIS PROMPT WOULD NOT COINCIDE WITH AN ERROR. THE FOLLOWING CONCOMITANT DEVICES WERE USED DURING THE PROCEDURE: ENDOSCOPE PLUS 30 DEGREE, TIP-UP FENESTRATED GRASPER, MARYLAND BIPOLAR FORCEPS, FENESTRATED BIPOLAR FORCEPS, SUREFORM 45 CURVED TIP STAPLER. A SITE HISTORY REVIEW SHOWED THAT WITH THE EXCEPTION OF THE SINGLE-USE STAPLER, THE OTHER INSTRUMENTS AND THE ENDOSCOPE WERE ALL USED IN SUBSEQUENT PROCEDURES WITH NO REPORTED COMPLAINTS. REVIEW OF THE EVENT BY AN INTUITIVE MEDICAL SAFETY OFFICER CONCLUDED THAT THE PATIENT WAS UNDERGOING A PULMONARY SEGMENTECTOMY WHEN THERE WAS AN INJURY TO THE PULMONARY ARTERY. THE MOMENT THE PULMONARY ARTERY RUPTURED WAS CAPTURED ON VIDEO WHICH OCCURRED DURING DISSECTION OF THIS VESSEL AND THE SEGMENTAL BRANCHES. THIS RESULTED IN SPLASHING THE CAMERA WHICH REQUIRED IMMEDIATE CLEANING OF THE LENS. THE SURGICAL TEAM SUBSEQUENTLY HAD DIFFICULTY RE-INSTALLING THE CAMERA AFTER CLEANING THE LENS AS EVIDENCED BY THE LOG INFORMATION. THE PATIENT WAS CONVERTED TO AN OPEN THORACOTOMY AND LATER REQUIRED ECMO. THE PATIENT EVENTUALLY DIED 10 DAYS LATER. THE ROOT CAUSE OF THE DEATH IS RELATED TO THE BLEEDING FROM THE PULMONARY ARTERY. ALTHOUGH THIS OCCURRED DURING DISSECTION OF THE VESSEL, HOW THE VESSEL WAS INITIALLY WEAKENED AND SUBSEQUENTLY RUPTURED IS UNKNOWN. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT. SECTION A2 AGE: THE PATIENT AGE WAS REPORTED AS "SIXTIES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED APICO-DORSAL LEFT LUNG SEGMENTECTOMY, A BRANCH OF THE PULMONARY ARTERY (PA) WAS INJURED; MASSIVE BLEEDING OCCURRED RESULTING IN AN EMERGENT CONVERSION TO AN OPEN PROCEDURE AND THE PATIENT ULTIMATELY EXPIRED. THE INTUITIVE CLINICAL TERRITORY ASSOCIATE WAS PRESENT AT THE PROCEDURE AND REPORTED THAT DURING DISSECTION AROUND THE PA THE VESSEL RUPTURED AND BLOOD IMMEDIATELY WAS PROJECTED ONTO THE ENDOSCOPE, OBSTRUCTING VISION. THE ENDOSCOPE WAS REMOVED FOR CLEANING OF THE TIP TO RESTORE VISION AND ATTEMPTS TO REINSTALL THE ENDOSCOPE WERE UNSUCCESSFUL, LEADING TO AN EMERGENT CONVERSION TO OPEN THORACOTOMY. THE ESTIMATED BLOOD LOSS WAS MORE THAN 3L AND THE PATIENT WAS IN HEMORRHAGIC SHOCK. THE PATIENT WENT INTO CARDIAC ARREST, INTERNAL CARDIAC MASSAGE WAS PERFORMED, AND THE PA WAS CLAMPED. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND THE SEGMENTECTOMY PROCEDURE WAS COMPLETED OPEN. THE PATIENT EXPIRED ON POSTOPERATIVE DAY 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901449 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| D DA VINCI INSTRUMENTS AND ACCESSORIES