BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1821113 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05269
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 27, 2007
    Report Date
    July 27, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAP PROCEDURE THE DEVICE FIRED MALFORMED CLIPS. THE SITE USED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO SURGERY, INC (CINCINNATI) NI D4HD7L

    Patients

    Seq Age Sex Outcome Treatment
    1