BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21249681 · Received January 28, 2025

    Report

    Report Number
    2955842-2025-00896
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    September 20, 2024
    Report Date
    January 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE VESSEL STEALER EXTEND BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA - PARAESOPHAGEAL SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT MALFUNCTIONED AND BEGAN TO LEAK A WHITE COLORED FLUID WHEN USED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ON 01/07/2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: VESSEL SEALER MALFUNCTIONED DURING USE. THE VESSEL SEALER BEGAN TO LEAK A WHITE COLORED FLUID WHEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240811 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K10240406 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES