BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21384123 · Received February 14, 2025

    Report

    Report Number
    2955842-2025-01618
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVESTIGATION IS IN PROGRESS. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED.

    Description of Event or Problem · 0

    ON 22-JAN-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT: (B)(4) STATING: JOINT BETWEEN SHAFT AND TIP OF DEVICE DISCONNECTED, RISK FOR PLASTIC PIECES IN PATIENTS BODY, ADDITIONALLY TROCAR WAS STUCK ON DEVICE TEMPORARILY. THE CUSTOMER REPORTED SERIOUS OR IMPORTANT MEDICAL EVENT. ISI FOLLOWED UP WITH THE CUSTOMER SITE AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151766 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-11 K102431009 0482

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Other DA VINCI INSTRUMENTS AND ACCESSORIES.