BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY INC.

    MDR report key: 2414945 · Received January 4, 2012

    Report

    Report Number
    2414945
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    July 30, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ETHICON
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING LAPARASCOPIC APPENDECTOMY WHEN THE SURGEON HAD DIFFICULTY OPENING THE INTERNAL STAPLING DEVICE. THE DEVICE EVENTUALLY OPENED AND THE PROCEDURE WAS ABLE TO BE COMPLETED AS PLANNED. NO ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY INC. INTERNAL STAPLING DEVICE GDW ETHICON ECHLON EC60A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1