BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 2875005 · Received December 13, 2012

    Report

    Report Number
    2875005
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 29, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE STAPLER WAS FIRED, THE STAPLES CAME OUT CROOKED. A NEW DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR NO OTHER THERAPIES