BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 1212069 · Received September 10, 2008

    Report

    Report Number
    1212069
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 24, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A DISPOSABLE INSTRUMENT, THE LIGAMAX. AFTER MULTIPLE USES, HE COMPLAINED THAT IT WAS NOT WORKING AND ANOTHER ONE WAS OPENED FOR USE DURING THE REST OF THE PROCEDURE. HE REQUESTED THAT THE ITEM BE SAVED FOR THE GENERAL SURGERY RESOURCE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR