BEUDAMED
    FDA Adverse Event Other Summary report: N

    CK COR-KNOT

    MDR report key: 3250484 · Received May 22, 2013

    Report

    Report Number
    1320468-2013-00003
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    LSI SOLUTIONS
    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 TWO DEVICES. THE MANUFACTURER'S ENGINEER EXAMINED THE TWO DEVICES AND THE REPORT THAT THE "CK 5MM COR-KNOT WERE NOT EASILY FITTING INTO THE DEVICE" 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
    226568 CK COR-KNOT VALVE SUTURING DEVICE GAW LSI SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR