BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 7510853 · Received May 14, 2018

    Report

    Report Number
    7510853
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 16, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLIP APPLIER DID NOT FULLY CLOSE SEVERAL CLIPS. IT WAS AN ETHICON MULTICLIP APPLIER #ER320, LOT NUMBER 2033118.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353419 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC. 2033118

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES