BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 4102864 · Received September 19, 2014

    Report

    Report Number
    1219930-2014-00843
    Date Received
    September 19, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    KOG
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USE, AFTER THE NEEDLE WAS UNLOADED. THE SURGICAL STAFF GRABBED THE ENDOSTITCH HANDLE BY THE "RABBIT EARS" AND WAS CUT. SHE RECEIVED STITCHES FOR THE CUT AND IS NOW ON LEAVE FROM THE HOSPITAL. ADDITIONAL INFORMATION REQUESTED VIA EMAIL. IS THIS A LEGAL CASE? THE LOT PROVIDED IS FOR A V-LOC RELOAD, WAS THIS IN THE DEVICE AT THE TIME OF THE INJURY?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584654 ENDO STITCH* 10MM SUTURING DEVICE SINGLE USE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL A DIVISON 173016 J4C1041X

    Patients

    Seq Age Sex Outcome Treatment
    1