BEUDAMED
    FDA Adverse Event Other Summary report: N

    CK COR-KNOT

    MDR report key: 3250473 · Received May 22, 2013

    Report

    Report Number
    1320468-2013-00002
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    LSI SOLUTIONS INC.
    Product Code
    GAW
    PMA / PMN Number
    K100593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY DID NOT IDENTIFY THE REPORTED CK COR-KNOT DEVICE. THE REPORTING FACILITY RETURNED FOUR DEVICES. THE MANUFACTURER'S ENGINEER EXAMINED THE FOUR DEVICES AND THE REPORT THAT THE "DEVICE FOR CINCHING VALVE SUTURE MISFIRED WHILE BEING DEPLOYED" COULD NOT BE REPLICATED. THE DEVICES WERE VISUALLY AND FUNCTIONALLY EXAMINED AND THE DEVICES MET THE SPECIFICATION REQUIREMENTS. A REVIEW OF TWO YEARS OF COMPLAINTS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS. THE FAILURE COULD NOT BE CONFIRMED ON THE REPORTED DEVICE. THEREFORE, NO REASONABLE OR DEFINED COURSE OF ACTION IS AVAILABLE BASED ON LACK OF EVIDENCE OF A CONFIRMED FAILURE MODE.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226569 CK COR-KNOT SUTURE, NONABSORBABLE, SYNTHETIC GAW LSI SOLUTIONS INC. 14955

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other