BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR-KNOT MIS COMBO KIT

    MDR report key: 20733424 · Received November 20, 2024

    Report

    Report Number
    20733424
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    May 8, 2024
    Report Date
    September 13, 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 MIS COMBO KIT. REF # 031082, EXP 02-28-2027, LOT # 3037009. WHEN THE SCRUB IS INSERTING THE COR-KNOT IT WOULD NOT PASS THRU EASILY IN ONE OF THE TIP. ORIGINAL PACKAGE NOT COMPROMISE, AND SENT TO MATERIAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314305 COR-KNOT MIS COMBO KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS, INC. 031082 3037009

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male