BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1112660 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01081
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/11/2008. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A CORONARY ARTERY BYPASS GRAFT. THE DEVICE WAS BEING USED AND THE CLIPS WERE LOADED CROOKED AND THE CLIPS WERE MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER GDO ETHICON ENDO-SURGERY, LLC NA E4K561

    Patients

    Seq Age Sex Outcome Treatment
    1