BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 14325815 · Received May 7, 2022

    Report

    Report Number
    2955842-2022-11461
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    January 3, 2020
    Report Date
    February 12, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS WAS PERFORMED. THE SUREFORM 60 STAPLER INSTRUMENT WAS USED AND FIRED TWO GREEN RELOADS. BOTH FIRINGS WERE COMPLETED PER THE LOGS WITH NO PAUSES FOR COMPRESSION. THERE WERE NO INCOMPLETE CLAMPS IN THE PROCEDURE. BESIDES THE GRIP RELEASE TOOL DETECTION, THERE WAS ONE INSTANCE OF A ¿REMOTE CENTER MONITOR¿ EVENT THAT INDICATES DURING TABLE MOTION, THE MOVEMENT OF ARM 1 HIT THE LIMIT AND THUS TABLE MOTION WAS STOPPED. THERE WERE NO FURTHER OCCURRENCES OF THIS BEHAVIOR. ROUGHLY 40 SECONDS AFTER THE LAST UNCLAMP EVENT, THE SYSTEM LOGS SHOW AN ERROR ASSOCIATED WITH THE SUREFORM INSTRUMENT INDICATING THAT THE TOOL WAS FORCE EXPIRED. FORCE EXPIRATION IS THE EXPECTED SYSTEM BEHAVIOR WHEN THE MRK IS USED. THE FOLLOWING ERRORS ARE ALSO ASSOCIATED WITH THE SUREFORM, ¿LOG_GRIP_RELEASE_TOOL_DETECTED¿ AND ¿ERROR_MIDDLEMAN_MANIP_MGR_MISUSE¿. ALL ERRORS WERE LOGGED AT THE SAME TIMESTAMP. THE USER MAY HAVE TURNED THE MANUAL RELEASE KNOB (MRK) ON THE SUREFORM INSTRUMENT, WHICH WOULD RESULT IN ALL ERRORS LOGGING AT THE SAME TIME. PER THE LOGS, THE LAST UNCLAMP WAS COMPLETED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A MEDICAL REVIEW OF THE EVENT INFORMATION PROVIDED WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING INFORMATION WAS PROVIDED: BASED ON THE INFORMATION IN THE DESCRIPTION OF EVENTS, IT IS LIKELY THAT THE PATIENT EXPIRED DUE TO CARDIOPULMONARY FAILURE. BASED UPON THE DESCRIPTION OF EVENTS THE EXTENT AS TO THE CONTRIBUTION OF THE INTUITIVE SURGICAL SYSTEM TO THE PATIENT¿S MORTALITY IS NOT KNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FOLLOWING A DA VINCI-ASSISTED SIGMOID COLECTOMY WITH COLO-ANAL ANASTOMOSIS PROCEDURE, THE PATIENT EXPIRED SECONDARY TO PULMONARY AND CARDIAC FAILURE. WHILE THERE WAS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE EXTENT AS TO THE CONTRIBUTION OF THE DA VINCI SURGICAL SYSTEM TO THE PATIENT¿S MORTALITY IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN (B)(6) FEMALE EXPIRED TWO DAYS AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY WITH COLO-ANAL ANASTOMOSIS SURGICAL PROCEDURE, WHICH WAS PERFORMED ON (B)(6) 2020. THE PATIENT WAS ILL PRIOR TO THE PROCEDURE, AND THE PATIENT EXPIRED SECONDARY TO PULMONARY AND CARDIAC FAILURE. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER, AN ISI REPRESENTATIVE, AND HE STATED THAT HE OBTAINED THE INFORMATION OF THE PATIENT'S DEATH FROM THE SURGEON ON (B)(6) 2020. THE PATIENT EXPIRED TWO DAYS POST-OPERATIVELY, ON (B)(6) 2020, SECONDARY TO PULMONARY AND CARDIAC FAILURE. IT WAS CONFIRMED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE ROBOTIC PROCEDURE, AND NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2020, UPON ADDITIONAL FOLLOW-UP, THE INITIAL REPORTER OBTAINED THE FOLLOWING INFORMATION FROM THE SURGEON: THE PATIENT HAD A COLOVESICAL FISTULA. THE PATIENT WAS REPORTED TO BE ILL PRIOR TO THE PROCEDURE. THE SURGEON HAD REPORTED THAT THERE WAS MINIMAL BLOOD LOSS OF 25 CC DURING THE PROCEDURE. THE PATIENT CODED AT 7:00 AM ON (B)(6) 2020 AFTER BEING FOUND UNRESPONSIVE. NO EPISODES OF TACHYCARDIA OR HYPOXIA WERE PREVIOUSLY REPORTED. THE PATIENT HAD "TRANSTHORACIC ECHO" AFTER CODING WHICH WERE CONSISTENT WITH "TAKOTSUBO CARDIOMYOPATHY." EKG SHOWED ST ELEVATIONS. A CHEST X-RAY SHOWED VASCULAR CONGESTION. AN ICU PHYSICIAN DIAGNOSED "TAKOTSUBO CARDIOMYOPATHY" AND INITIATED MYOCARDIAL INFARCTION (MI) PROTOCOL ON (B)(6) 2020. CARE WAS WITHDRAWN ON (B)(6)2020. BASED ON THE SYSTEM LOG REVIEW, IT WAS IDENTIFIED THAT THE MANUAL RELEASE KNOB (MRK), THE INSTRUMENT'S GRIP RELEASE TOOL, WAS USED ON THE SUREFORM 60 STAPLER INSTRUMENT. THE SURGEON, WHEN ASKED ABOUT THE USE OF THE MRK, REPORTED THE FOLLOWING: THERE WAS A NEW OR TECH IN THE ROOM WHO TRIED TO RELEASE THE SUREFORM 60 STAPLER INSTRUMENT FROM THE INSTRUMENT ARM. HE STATED THAT THE SUREFORM 60 STAPLER INSTRUMENT WOULD NOT RELEASE AND THE OR TECH STARTED TO TURN THE MRK. THE STAPLER INSTRUMENT WAS NOT GRASPING ANY TISSUE AT THE TIME. IT WAS CONFIRMED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE ROBOTIC PROCEDURE, AND NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. AS A RESULT, THE SINGLE USE INSTRUMENTS AND ACCESSORIES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375813 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES