BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 19889989 · Received August 2, 2024

    Report

    Report Number
    2955842-2024-17794
    Event Type
    Death
    Date Received
    August 2, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 5, 2024
    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
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INVESTIGATIONS COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED (I.E. PROCEDURE/EVENT DATE, UNCONFIRMED SURGEON NAME, PROCEDURE TYPE): EVENT VERIFICATION, SYSTEM/INSTRUMENT LOG REVIEW FOR THE EVENT, PROCEDURE INFORMATION. THE USER FACILITY HAS TWO DAVINCI ROBOTIC SYSTEMS. THE INFORMATION IN SECTION D, SUSPECT MEDICAL DEVICE, IS POTENTIALLY THE DEVICE USED IN THE EVENT. THEIR OTHER DAVINCI SYSTEM IS MODEL# 380652-55, SERIAL# (B)(6), UDI (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON BOTH OF THE DAVINCI SYSTEMS CURRENTLY IN USE AT THIS HOSPITAL WITH NO NON-CONFORMANCES IDENTIFIED TO BE RELATED TO THIS EVENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY REPORTED EVENTS RELATED TO THIS EVENT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE TYPE OF PROCEDURE AND THE EVENTS AROUND THIS PATIENT¿S DEATH WERE NOT REPORTED. NO ALLEGATIONS AGAINST ANY INTUITIVE PRODUCTS WERE MADE. INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL SYSTEM OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPIRED. THE INTUITIVE SURGICAL CLINICAL SALES REPRESENTATIVE WAS NOTIFIED OF THE PATIENT DEATH BY A SURGEON; NO ADDITIONAL INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION WERE MADE BUT HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741034 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Death DA VINCI INSTRUMENTS AND ACCESSORIES