BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 3042671 · Received April 3, 2013

    Report

    Report Number
    MW5029638
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ETHICON ENDO SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF RECTOSIGMOID CANCER TO OPERATING ROOM FOR LOW ANTERIOR RESECTION. DURING THE CASE, THE STAPLES FAILED TO CLOSE AFTER THE STAPLER WAS FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136220 ETHICON PROXIMATE GDW ETHICON ENDO SURGERY, LLC TX60G K4C13T

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR APPLIERS LG CLIPS CAT #MCL20 PART #ETHMCL20| ETHICON ENDO-SURGERY CLIP APPLIER LIGACLIP