BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1318780 · Received February 23, 2009

    Report

    Report Number
    1527736-2008-01284
    Event Type
    Malfunction
    Date Received
    February 23, 2009
    Date of Event
    February 6, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS WILL NOT HOLD AFTER PLACING. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JV8C

    Patients

    Seq Age Sex Outcome Treatment
    1