BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED LONG APPLIER

    MDR report key: 1316834 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-02080
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 04/03/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CABG PROCEDURE, THE CLIPS WERE SCISSORING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED LONG APPLIER GDO GDO ETHICON ENDO SURGERY, INC. NA E4K40Y

    Patients

    Seq Age Sex Outcome Treatment
    1