BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 2022449 · Received March 6, 2011

    Report

    Report Number
    2022449
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 6, 2011
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO STITCH SUTURE DEVICE BECAME JAMMED, UNABLE TO LOAD OR UNLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SUTURE DEVICE OCW COVIDIEN 173016 (1) N0M0235, (2) N0L0631

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR