BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 3831941 · Received April 9, 2014

    Report

    Report Number
    3831941
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A DISPOSABLE ENDO STITCH DEVICE WAS BEING USED DURING A SURGICAL PROCEDURE. THE DOCTOR OPENED 3 DIFFERENT DEVICES AND THE SURGIDAC NEEDLES KEPT GETTING STUCK IN THE ENDO STITCH DEVICE. FINALLY A FOURTH DEVICE WAS OPENED AND IT FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213361 ENDO STITCH ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN * 2 J3M0975X 1 J3L0584X

    Patients

    Seq Age Sex Outcome Treatment
    1 *