BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA

    MDR report key: 3032078 · Received March 28, 2013

    Report

    Report Number
    3032078
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MEDIUM LIGACLIP APPLIER WAS CUTTING AS IT WAS CLIPPNG THE TISSUE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127621 LIGACLIP MCA CLIP, IMPLANTABLE FZP ETHICON ENDO SURGERY * A94275P00

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR