BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5

    MDR report key: 1870777 · Received September 23, 2010

    Report

    Report Number
    1870777
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ETHICON
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLIP APPLIER WORKED FOR A FEW THEN BECAME OBSTRUCTED BY THE CLIPS AND UNABLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5 APPLIER, SURGICAL CLIP GDO ETHICON EL5ML G4TR8H

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR