BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE-KNOT SUTURE FASTENER

    MDR report key: 20106693 · Received August 29, 2024

    Report

    Report Number
    MW5159046
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 23, 2024
    Manufacturer
    LSI SOLUTIONS INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "COR NOT DEVICE" LOT #: 862774, REF #: 030800 OPENED FOR AVR CASE. -DEVICE MISFIRED, PULLING SUTURE/PLEDGET, SURGEON HAD TO REMOVE THE SUTURE AND PLEDGETS, ENSURE ALL THE PLEDGETS WERE ACCOUNTED FOR AND RESEW BACK IN. NEW DEVICE OPENED WITH SAME LOT NUMBER, NOT BEING ABLE TO BE LOADED CORRECTLY. THIRD DEVICE OPENED WITH DIFFERENT LOT NUMBER AND WORKED CORRECTLY. -DEVICE ISSUE CAUSED INCREASED CASE TIME/TIME ON BYPASS. REPORTED TO OR(OPERATING ROOM) MANAGERS REF #: 030800, THE LOT #: 862774, EXP DATE 07-31-2025, QTY WAS 2 PER BX. TOTAL OF 4 TO RETURN; ITEMS USED WERE DISPOSED OF - PLAN TO RETURN REMAINING PACKAGE TO THE MANUFACTURER FOR REFUND AND INFORM THEM OF ISSUES AT THAT TIME (NOT YET DONE AS OF 08/23/2024). REF REPORT: MW5159047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341842 CORE-KNOT SUTURE FASTENER INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS INC. 030800 862774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown