BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 3232385 · Received July 8, 2013

    Report

    Report Number
    3232385
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 8, 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

    DURING SETUP OF OR ROOM, SCRUB TECH CHECKED THE STAPLER, STAPLES WERE NOT LOADING PROPERLY. LIGACLIP REMOVED FROM THE STERILE FIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309211 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC. * K4CG21

    Patients

    Seq Age Sex Outcome Treatment
    1 *