BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 2842741 · Received October 5, 2012

    Report

    Report Number
    2842741
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STAPLES WERE MALFORMED. THE STAPLES WOULD NOT CLOSE, STRAIGHT AND SECURE. THE CLIPS WERE USED DURING REMOVAL OF THE GALLBLADDER AND THEIR MALFORMATION DID NOT SEEM TO INTERFERE WITH THIS PROCESS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPE AND/OR ACCESSORIES FZP ETHICON ENDO SURGERY, INC. * J4C59E

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR