BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21600419 · Received March 13, 2025

    Report

    Report Number
    2955842-2025-06753
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 14, 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
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE TENACULUM FORCEPS INSTRUMENT FOR FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 0

    ON 14-FEB-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT (MDR) WITH REPORT # (B)(4). STATING: "DA VINCI TENACULUM INSTRUMENT 8MM MALFUNCTIONED WHILE BEING OPENED BY SURGEON INSIDE OF PT. BROTHER WIVES WERE VISUALIZED BY THEM AFTER REMOVED. CHARGE NURSE NOTIFIED. X-RAY ABD R/O FOREIGN BODY ORDERED. MIDAS AND MEDWATCH COMPLETED." ON 10-MAR-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ANOTHER MDR STATING: "DAVINCI ROBOT TENACULUM INSTRUMENT 8MM MALFUNCTIONED WHILE BEING OPENED BY SURGEON INSIDE OF PATIENT. BROKEN WIRES WERE VISUALIZED BY THEM AFTER REMOVAL. CHARGE NURSE NOTIFIED. X-RAY ABD R/O FOREIGN BODY ORDERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700306 ENDOWRIST TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 470207-10 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES