BEUDAMED
    FDA Adverse Event Summary report: N

    TK TI-KNOT DEVICE

    MDR report key: 3915306 · Received June 10, 2014

    Report

    Report Number
    3915306
    Date Received
    June 10, 2014
    Date of Event
    March 14, 2014
    Report Date
    June 10, 2014
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    GCJ
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    THE JAWS OF INSTRUMENT WERE MISALIGNED AND WOULD NOT ALLOW FOR SUTURE TO BE LOADED INTO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338224 TK TI-KNOT DEVICE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ LSI SOLUTIONS, INC. * 17012

    Patients

    Seq Age Sex Outcome Treatment
    1 *