BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 17222595 · Received June 29, 2023

    Report

    Report Number
    2955842-2023-16681
    Event Type
    Death
    Date Received
    June 29, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 2, 2023
    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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION RESULTING IN THE PATIENT'S DEATH CANNOT BE DETERMINED. A REVIEW OF THE DEVICE LOGS WAS COMPLETED AND IT WAS DETERMINED THAT THE MULTI-USE INSTRUMENTS AND THE ENDOSCOPE USED DURING THE PROCEDURE HAVE BEEN USED IN SUBSEQUENT PROCEDURES. A SITE HISTORY REVIEW REVEALED NO COMPLAINTS HAVE BEEN FILED AGAINST ANY OF THE INSTRUMENTS OR THE ENDOSCOPE. AN ADVANCED SYSTEM LOG REVIEW FOR THE REPORTED PROCEDURE DATE, AND FOR THE SUBSEQUENT FIVE PROCEDURES AFTER THE EVENT, FOUND NO NOTABLE EVENTS. A DEVICE HISTORY RECORD REVIEW FOR THE SYSTEM AND INSTRUMENTS DID NOT IDENTIFY ANY ISSUES DURING MANUFACTURING THAT WOULD BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE EVENT WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT ACCORDING TO THE INFORMATION IN THE SUMMARY OF EVENTS, THIS PATIENT DIED AS A RESULT OF AN INJURY TO THE VENA CAVA DURING A PLANNED RADICAL CYSTECTOMY WITH ILEAL CONDUIT PROCEDURE. THE DETAILS OF HOW THE INJURY OCCURRED, WHAT INSTRUMENTS MAY HAVE BEEN INVOLVED, OR WHAT STEPS OR ATTEMPTS WERE TAKEN TO MITIGATE THE INJURY WERE NOT PROVIDED. INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT PROCEDURE, THE PATIENT'S VENA CAVA WAS INJURED, AND THE PATIENT ULTIMATELY EXPIRED WHILE THE PROCEDURE WAS CONVERTED TO OPEN. THE HOSPITAL DA VINCI ROBOTICS COORDINATOR INFORMED THE INTUITIVE SURGICAL, INC (ISI) CLINICAL SALES REPRESENTATIVE THAT THE VENA CAVA WAS INJURED AND THERE WAS BLEEDING THAT THEY WERE ABLE TO CONTROL AT FIRST. HOWEVER, AS THEY WERE CONVERTING THE CASE TO OPEN TO ADDRESS THE INJURY, CONTROL OF THE BLEEDING WAS LOST AND THE PATIENT BLED OUT AND PASSED AWAY. THE HOSPITAL RISK MANAGER PROVIDED INFORMATION THAT THEY WERE NOT APPRISED OF ANY MENTION OR THINKING THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF EQUIPMENT. IF THEY THOUGHT THAT WAS THE CASE THEY WOULD HAVE REACHED OUT TO THE VENDOR DIRECTLY. THE RISK MANAGER WAS PROVIDED WITH A LIST OF ADDITIONAL QUESTIONS REGARDING THE EVENT AND RESPONDED THAT THEY WOULD ATTEMPT TO GATHER THE ANSWERS TO THE QUESTIONS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245757 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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