BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21440854 · Received February 22, 2025

    Report

    Report Number
    2955842-2025-01990
    Event Type
    Malfunction
    Date Received
    February 22, 2025
    Date of Event
    January 28, 2025
    Report Date
    October 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END.

    Additional Manufacturer Narrative · 0

    BASED ON AVAILABLE INFORMATION, IT HAS BEEN DETERMINED THAT THE INSTRUMENT INVOLVED WITH THIS COMPLAINT MEETS THE CRITERIA FOR ISIFA2024-09-C. HENCE, SECTION H9 WAS UPDATED TO REFLECT THIS LINKAGE. CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE. CORRECTION TO ANNEX CODES: ANNEX CODE G WAS UPDATED TO G04121. ANNEX CODE A WAS UPDATED TO A040605. CORRECTION H9: THE DATE IN SECTION H9 SHOULD BE 02/07/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT'S FIBER WIRE SNAPPED. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110108 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230817 0232 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES