BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19582012 · Received June 21, 2024

    Report

    Report Number
    2955842-2024-15956
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 24, 2024
    Report Date
    May 24, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K162411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL COLORECTAL PROCEDURE, THE CUSTOMER MENTIONED THAT THEY HAVE IDENTIFIED A FOREIGN BODY LEFT IN THE PATIENT. THEY ARE UNABLE TO IDENTIFY WHAT THIS MIGHT BE. HOWEVER, IT WAS RING SHAPED AND THEIR THINKING THAT IT COULD POSSIBLY BE THE METAL END OF THE 12-8MM REDUCER. THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103671 ENDOWRIST REDUCER NAY INTUITIVE SURGICAL, INC 470381 N/A

    Patients

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