BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 16969170 · Received May 19, 2023

    Report

    Report Number
    2955842-2023-13759
    Event Type
    Death
    Date Received
    May 19, 2023
    Report Date
    April 19, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF DEATH IS UNABLE TO BE DETERMINED. NO PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR EVALUATION. INFORMATION REGARDING THE SPECIFIC SURGICAL PROCEDURE AND DATE PERFORMED WAS NOT PROVIDED. INSUFFICIENT PROCEDURAL INFORMATION DOES NOT ALLOW FOR SYSTEM OR INSTRUMENT LOG REVIEWS TO BE PERFORMED. A DEVICE HISTORY RECORD (DHR) FOR THE DA VINCI SYSTEM INVOLVED WITH THE REPORTED EVENT WAS COMPLETED AND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. REVIEW OF THE EVENT BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER CONCLUDED THAT THERE IS NO SIGNIFICANT INFORMATION PROVIDED IN THE SUMMARY OF EVENTS. THE PROCEDURE PERFORMED AND CIRCUMSTANCES AROUND THE DEATH ARE UNAVAILABLE. THEREFORE, INSUFFICIENT INFORMATION IS PROVIDED TO ASCERTAIN IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS DEATH.

    Description of Event or Problem · 0

    AFTER AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED BY A COLORECTAL SURGEON, THE PATIENT EXPIRED ON AN UNKNOWN POST-OPERATIVE DAY. AN INTUITIVE SURGICAL, INC. (ISI) EXECUTIVE SALES REPRESENTATIVE (ESR) SPOKE WITH THE DIRECTOR OF ROBOTICS AT THE FACILITY WHO BELIEVES THE PROBABLE CAUSE OF DEATH WAS THE FAILURE OF AN EXTRACORPOREAL ANASTOMOSIS PERFORMED OPEN AFTER THE DA VINCI SYSTEM WAS UNDOCKED. IT IS ALSO BELIEVED THE PATIENT WAS NEVER DISCHARGED FROM THE HOSPITAL, DEVELOPED A POSTOPERATIVE BOWEL OBSTRUCTION AND THE PATIENT'S DEATH WAS POTENTIALLY RELATED TO ASPIRATION. IT WAS ALSO STATED THAT THERE WAS NO ALLEGATION OF A DAVINCI SYSTEM OR PRODUCT ISSUE. THE DIRECTOR OF ROBOTICS AND THE OPERATING SURGEON DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644331 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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