BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 579180 · Received February 25, 2005

    Report

    Report Number
    2647580-2005-00101
    Event Type
    Malfunction
    Date Received
    February 25, 2005
    Date of Event
    January 11, 2005
    Report Date
    January 25, 2005
    Manufacturer
    PONCE - USS
    Product Code
    KDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A CHOLECYSTECTOMY. THE BAG BROKE AS THE SPECIMEN WAS PLACED INSIDE. THE SURGEON WAS ABLE TO RETRIEVE THE BAG AND THE SPECIMEN WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL DISPOSABLE SPECIMEN RETRIEVAL DEVICE KDW PONCE - USS NA P4K677

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN