BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR-KNOT®

    MDR report key: 20565788 · Received October 30, 2024

    Report

    Report Number
    20565788
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 14, 2024
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    COR KNOT LOADS GRINDING AND DID NOT LOAD PROPERLY. APPEARED THAT THE BLADE WAS NOT FULLY DISENGAGING. ONE JAMMED AND MISFIRED. NO HARM TO PATIENT. OPENED A NEW ONE. INCIDENT HAS BEEN REPORTED TO LSI & RETURNED. RGA#, TRACKING#. MANUFACTURER RESPONSE FOR COR KNOT DEVICE, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA#

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019863 COR-KNOT® INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS, INC. 1562344

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male