BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX MCA SMALL APPLIER

    MDR report key: 1831439 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08545
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    November 7, 2007
    Report Date
    December 3, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    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

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT, THE FIRST DEVICE SCISSORED THE CLIP AND CUT A MAMMARY ARTERY, SO THEY USED A CLIP TO STOP THE BLEEDING. THE SECOND DEVICE HAD CLIPS COMING OUT AT AN ANGLE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX MCA SMALL APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4J392

    Patients

    Seq Age Sex Outcome Treatment
    1