BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 13256626 · Received January 13, 2022

    Report

    Report Number
    2955842-2022-10051
    Event Type
    Death
    Date Received
    January 13, 2022
    Date of Event
    June 9, 2021
    Report Date
    June 17, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT'S DEATH CANNOT BE DETERMINED OR IS UNKNOWN. HOWEVER, THE SURGEON CLAIM THAT THE DA VINCI SURGICAL SYSTEM "HAD NO BEARING ON THE CAUSES OR ULTIMATE OUTCOME OF HE CASE." THERE WAS NO REPORT OR KNOWN ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE COMPLAINT HISTORY REVIEW WAS CONDUCTED ON (B)(6) 2021 AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT OR EVENT. A SYSTEM ERROR LOG REVIEW WAS CONDUCTED ON (B)(6) 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. A SINGLE USE SUCTION IRRIGATOR WAS USED DURING THE CASE WITH ALL OTHERS BEING REUSABLE INSTRUMENTS. WHILE NONE OF THE REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AS OF (B)(6) 2021, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST ANY OF THE INSTRUMENTS. AN ISI ADVANCED FAILURE ANALYST (AFA) ENGINEER CONDUCTED AN ADDITIONAL REVIEW OF THE SYSTEM LOGS AND RESULTS WERE AS FOLLOWS: ALL OF THE ERRORS/ENTRIES IN THE LOGS FOR THE PROCEDURE WERE CLASS 0 (SYSTEM SERVICE ADVISORY; NO FAULT REACTION) AND CLASS 8 (ENGINEERING EVENT INFORMATIONAL; NO FAULT REACTION) SO NONE OF THESE WOULD SUGGEST A PRODUCT ISSUE. IT APPEARED AS THOUGH THE CUSTOMER RESTARTED THE SYSTEM MID PROCEDURE BUT NOT DUE TO ANY ERRORS. THE ERROR 100 ENTRIES WERE THAT THE SET UP JOINT (SUJ) WAS MOVED WITHOUT BEING CLUTCHED AND WOULD LIKELY BE DUE TO THE CUSTOMER TRYING TO MOVE THE SUJ WITHOUT CLUTCHING. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED BY THE CUSTOMER TO ISI FOR REVIEW. A REVIEW OF THE EVENT INFORMATION PROVIDED WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING WAS NOTED: ¿ACCORDING TO THE INFORMATION IN THE DESCRIPTION OF EVENTS, A PATIENT WITH A REPORTED HISTORY OF ALCOHOL ABUSE AND ¿LIVER PROBLEMS¿ BEGAN TO UNCONTROLLABLY HEMORRHAGE FROM THE PORTAL VEIN DURING A DA VINCI ASSISTED CHOLECYSTECTOMY WHICH EVENTUALLY LED TO THE PATIENT¿S DEATH. THE EVENT THAT CAUSED THE PORTAL VEIN TO BLEED IS UNKNOWN. ALTHOUGH IT WAS REPORTED THAT THE SURGEON BELIEVES THAT THE ¿ROBOT¿ DID NOT CAUSE THE EVENT, THERE IS CURRENTLY NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THE PORTAL VEIN HEMORRHAGE.¿ DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THE PATIENT EXPERIENCED, ¿PORTAL VEIN BLEEDING.¿ THE SURGEON TRIED TO GET CONTROL OF THE BLEEDING AND CALLED IN ANOTHER SURGEON. THE PATIENT WAS EMERGENCY TRANSFERRED TO AN UNSPECIFIED HOSPITAL AND ULTIMATELY EXPIRED. ALTHOUGH THE SURGEON DOES NOT BELIEVE THAT THE ¿ROBOT¿ CAUSED THE EVENT, THERE IS NOT ENOUGH INFORMATION PROVIDED TO DETERMINE THE CAUSE OF THE PORTAL VEIN HEMORRHAGE THAT RESULTED IN THE PATIENT'S DEMISE. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE COMPLAINT REVIEW.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE ON A MALE PATIENT ON (B)(6) 2021, THERE WAS ¿PORTAL VEIN BLEEDING.¿ THE CUSTOMER TRIED TO GET CONTROL OF THE BLEEDING AND CALLED IN ANOTHER SURGEON. THE PATIENT WAS THEN EMERGENCY TRANSFERRED TO AN UNSPECIFIED HOSPITAL. THE PATIENT REPORTEDLY EXPIRED THAT SAME DAY. IT WAS REPORTED THAT THE PATIENT WAS AN "EXCESSIVE ALCOHOLIC AND HAD LIVER PROBLEMS.¿ IN ADDITION, THE SURGEON INDICATED THAT HE DOES NOT BELIEVE THE EVENT WAS RELATED TO THE ROBOT. THE SURGEON STATED THE FOLLOWING: "DETAILS OF THE EVENT ARE ACCURATE IN YOUR REPORT. USE OF THE ROBOT HAD NO BEARING ON THE CAUSES OR ULTIMATE OUTCOME OF THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962021 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES