BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 17981727 · Received October 21, 2023

    Report

    Report Number
    2955842-2023-19485
    Event Type
    Death
    Date Received
    October 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT (PATIENT IDENTIFIER (B)(6)) REPRESENTS INFORMATION SHARED FROM A SURGEON TO AN ISI CLINICAL SALES REPRESENTATIVE WHILE DISCUSSING AN UNRELATED EVENT. THE SURGEON HEARD THE INFORMATION DURING A BRIEF DISCUSSION WITH THE COUNTY MEDICAL EXAMINER THAT WAS DESCRIBED AS A COLLEAGUE-TO-COLLEAGUE OBSERVATION. A SEPARATE MEDWATCH REPORT (PATIENT IDENTIFIER (B)(6)) WAS SUBMITTED FOR THE EVENT THAT ELICITED THE INFORMATION FROM THE ME WHEN THE AUTOPSY INFORMATION FOR THE SURGEON'S PATIENT WAS BEING DISCUSSED. A SEARCH OF THE COMPLAINT HANDLING DATABASE FROM 2013 THROUGH PRESENT DID NOT FIND ANY SIMILAR CASES FOR THE USER FACILITY PROVIDED. NO PRODUCT INVESTIGATION COULD BE PERFORMED FOR THE PROSTATECTOMY CASE DUE TO INSUFFICIENT INFORMATION. NO PRODUCT INVESTIGATION COULD BE PERFORMED FOR THE SPLENECTOMY CASE AS THE ME OFFICE COULD NOT LOCATE ANY RECORDS IN THEIR FILES THAT MATCH THE DESCRIPTION.

    Description of Event or Problem · 0

    DURING INVESTIGATION OF AN UNRELATED EVENT, A SURGEON NOTIFIED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT THE COUNTY MEDICAL EXAMINER (ME), WHILE PROVIDING AUTOPSY RESULTS FOR THE UNRELATED EVENT, "RECALLED TWO PREVIOUS PATIENT DEATHS CAUSED BY ROBOTIC STAPLE LINES NOT HOLDING UP ON ARTERIES AND CAUSING BLEEDING." THE ME RECALLED THAT ONE PATIENT HAD RECEIVED A ROBOTIC-ASSISTED PROSTATECTOMY, AND THE OTHER PATIENT RECEIVED A ROBOTIC-ASSISTED SPLENECTOMY. THERE WAS NO ADDITIONAL INFORMATION EXCHANGED, OTHER THAN THE EVENTS OCCURRED AT DIFFERENT HOSPITALS. THE MEDICAL EXAMINERS OFFICE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION. THE ME ASSISTANT STATED THEY WOULD REVIEW PREVIOUS CASES TO DETERMINE IF THERE WERE ANY SIMILAR CASES. UPON FOLLOW UP, THE ME ASSISTANT REPORTED FINDING A PROSTATECTOMY CASE FROM 2015, AND THE ONLY INFORMATION THEY COULD SHARE WAS THE DATE OF DEATH AND HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. THERE WERE NO SIMILAR SPLENECTOMY CASES FOUND IN THE MEDICAL EXAMINERS RECORDS. THE MEDICAL EXAMINER DECLINED TO PROVIDE ANY FURTHER INFORMATION AND DESCRIBED THE CONVERSATION AS A BRIEF COLLEAGUE-TO-COLLEAGUE OBSERVATION. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983914 DA VINCI SURGICAL SYSTEM N/A NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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