BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR-KNOT

    MDR report key: 19654869 · Received July 2, 2024

    Report

    Report Number
    19654869
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 11, 2024
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COR-KNOT SUPPLY WITH LOT NUMBER OF 3243826 HAD FAULTY HANDLE RELEASE MECHANISM AND WAS NOT CUTTING PER OPERATING SURGEON. NO PATIENT INJURY OCCURRED AT TIME OF USE OF SAID SUPPLY; HOWEVER, A NEW COR-KNOT SYSTEM HAD TO BE OPENED. SURGEON REQUESTED PATIENT NOT BE CHARGED FOR FAULTY EQUIPMENT, SAID LOT NUMBER BE REMOVED, AND MANAGEMENT BE MADE AWARE, ALL OF WHICH WAS COMPLETED AS HE ASKED. SUPPLY LISTED IN COMPUTER AS A WASTE ALONG WITH BAD LOT NUMBER. SHELF WAS CHECKED FOR ANY OTHER LOT NUMBER AND NONE WERE FILED. LSI SOLUTIONS COMPANY WAS CALLED, AND INCIDENT FILED WITH THEM. PRODUCT SECURED WITH CLINICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759756 COR-KNOT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS, INC. 3243826

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male