BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20607177 · Received November 5, 2024

    Report

    Report Number
    2955842-2024-21543
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT 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

    ON (B)(6) 2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 3900900000-2024-8008 STATING: SURGEON USING MEGA SUTURECUT NEEDLE DRIVER WHEN INSTRUMENT FAILED, WIRE BROKE INSIDE INSTRUMENT. INSTRUMENT REMOVED FROM PATIENT INTACT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625913 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES