BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO STITCH

    MDR report key: 3915330 · Received June 10, 2014

    Report

    Report Number
    3915330
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    PRODUCT HANDLE IS TOO STIFF AND DOES NOT OPERATE EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338226 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN * J3K2021X

    Patients

    Seq Age Sex Outcome Treatment
    1 *