BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO STITCH

    MDR report key: 3915262 · Received June 10, 2014

    Report

    Report Number
    3915262
    Date Received
    June 10, 2014
    Date of Event
    April 9, 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

    INSTRUMENT IS TOO STIFF AND NOT EASY TO OPERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338486 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016 J3M0792X

    Patients

    Seq Age Sex Outcome Treatment
    1