BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 1344430 · Received March 16, 2009

    Report

    Report Number
    MW5010314
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    March 10, 2009
    Report Date
    March 13, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE DIFFERENT LIGACLIP APPLIERS WERE USED AND ALL 3 OF THEM MALFUNCTIONED. ITEM DESCRIPTION IS LIGACLIP 12MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER WHICH CONTAINS 20 LARGE TITANIUM CLIPS. LOT# C4FT87, EXP: 10-2011. LOT# E4LD5H, EXP: 5-2013. AND LOT# D4J13X EXP: 7-2012. THE PROBLEM HAS ALREADY BEEN REPORTED TO THE ETHICON DEVICE COMPLAINT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC LIGACLIP 12-L GDO ETHICON ENDO-SURGERY, LLC ER420 CFFT87
    2 ETHICON ENDO-SURGERY, LLC LIGACLIP 12-L GDO ETHICON ENDO-SURGERY, LLC E4LD5H
    3 ETHICON ENDO-SURGERY, LLC LIGACLIP 12-L GDO ETHICON ENDO-SURGERY, LLC D4J13X

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR