BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TK® TI-KNOT® DEVICE

    MDR report key: 8960536 · Received September 4, 2019

    Report

    Report Number
    8960536
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 1, 2019
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    HCF
    UDI-DI
    00850200006094
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS OPERATING ROOM STAFF WERE SETTING UP FOR A SURGICAL CASE, THEY TRIED OPENING THE LSI SOLUTIONS TK TI-KNOT (REF 030404, LOT # 739987) DEVICE PACKAGING BUT IT WOULDN'T OPEN PROPERLY. THE PACKAGING WOULDN'T PEEL OPEN AS IT NORMALLY WOULD, BUT RATHER THE PAPER COVER WAS PEELING IN HALF. SINCE THE STAFF COULDN'T GUARANTEE THE STERILITY OF THE CONTENTS OF THE PACKAGE/DEVICE, THEY COULDN'T USE THE DEVICE AND HAD TO OPEN A SECOND DEVICE FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754509 TK® TI-KNOT® DEVICE INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS, INC. 030404 739987 00850200006094

    Patients

    Seq Age Sex Outcome Treatment
    1