BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT ND

    MDR report key: 20179813 · Received September 10, 2024

    Report

    Report Number
    20179813
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON USING MEGA SUTURE CUT NEEDLE DRIVER DURING ROBOTIC UMBILICAL HERNIA REPAIR. INSTRUMENT WAS IN THE BELLY AND SUDDENLY WIRE IN BETWEEN TEETH WAS EXPOSED WHILE INSTRUMENT BEING USED. INSTRUMENT REMOVED INTACT AND NEW INSTRUMENT OPENED AND UTILIZED. DEFECTIVE INSTRUMENT TAGGED AND TAKEN DOWN TO DECONTAMINATION AND GIVEN TO [NAME REDACTED]. ALL MANAGEMENT STAFF AND PERI-OP STAFF INFORMED AND AWARE VIA GROUP ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227065 MEGA SUTURECUT ND SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 471309 K102312070345

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown