BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 2992126 · Received March 1, 2013

    Report

    Report Number
    2992126
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEN MM LIGACLIP USED THE CLIPS WOULD NOT CLOSE COMPLETELY WHEN DEPLOYED, AND ANOTHER STAPLER WITH SAME LOT # WAS USED WITH THE SAME PROBLEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89438 LIGACLIP CLIP APPLIER FZP ETHICON ENDO-SURGERY, INC. * J4CG9Z

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR