BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CURVED INTRALUMINAL

    MDR report key: 3890034 · Received June 2, 2014

    Report

    Report Number
    3890034
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    August 26, 2013
    Report Date
    June 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING EXPLORATORY PROCEDURE, THE ETHICON STAPLER MISFIRED CAUSING A LINEAR MUSCOSAL TEAR OF 3CM TO THE UPPER RECTAL STUMP. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322526 ENDOSCOPIC CURVED INTRALUMINAL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, INC. * F4P84Y

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NOT KNOWN.