BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT

    MDR report key: 3110507 · Received May 8, 2013

    Report

    Report Number
    3110507
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DAVINCI MEGA SUTURECUT NEEDLE DRIVER BROKE DURING USE. THE WIRES AT THE TIP OF THE INSTRUMENT BROKE DURING THE SUTURING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INGUINAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200168 MEGA SUTURECUT SYSTEM, SURGICAL NAY INTUITIVE SURGICAL, INC 8MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR