BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED APPLIER

    MDR report key: 1904451 · Received February 11, 2008

    Report

    Report Number
    1527736-2008-00809
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 17, 2008
    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
    GA, 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 AN UNK PROCEDURE, THE DEVICE FIRED A MALFORMED CLIP. 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 APPLIER GDO ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4JH4C

    Patients

    Seq Age Sex Outcome Treatment
    1