BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20694085 · Received November 15, 2024

    Report

    Report Number
    20694085
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE WIRE CAME OUT FROM THE LIVE COATING. CHANGED TO NEW ROBOTICS IRRIGATION. NO PATIENT HARM. INCIDENT REPORT & RETURNED TO INTUITIVE. RGA#, TRACKING#. MANUFACTURER RESPONSE FOR SUCTION IRRIGATOR, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196313 ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 480299

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female