BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR-KNOT

    MDR report key: 20321121 · Received September 27, 2024

    Report

    Report Number
    20321121
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 20, 2024
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT REPORT FOR A MEDICAL DEVICE MALFUNCTION (COR-KNOT DEVICE) REF # 031082, LOT # 2277968. WHEN THE CST GAVE THE DEVICE TO THE SURGEON, SHE SAID IT WAS HARD TO PRESS AND DEPLOY THE KNOT, AND THE COR-KNOT WAS HARD TO REMOVE FROM THE TIP. DEVICE SENT WITH THE ORIGINAL PACKAGE TO SUPPLIES DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372719 COR-KNOT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS, INC. 031082 2277968

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female