BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH

    MDR report key: 1070215 · Received June 27, 2008

    Report

    Report Number
    1070215
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ENDOPOUCH RETRIEVER DEVICE "WOULD NOT RETRACT WHEN RETRIEVING SPECIMEN" AND "NEEDED REPLACEMENT." THE COMPANY REPRESENTATIVE HAS BEEN MADE AWARE AND WILL COME TO PICKUP THE DEVICE AT THEIR EARLIEST CONVENIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVAL DEVICE, ENDOSCOPIC GCJ ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR