BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCATCH GOLD 10MM SPECIMEN POUCH

    MDR report key: 621230 · Received July 12, 2005

    Report

    Report Number
    2647580-2005-00396
    Event Type
    Injury
    Date Received
    July 12, 2005
    Date of Event
    April 26, 2005
    Report Date
    June 16, 2005
    Manufacturer
    PONSE - USS
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING THE REMOVAL OF THE LEFT OVARY DUE TO A MASS PRESENT. DURING THE PROCEDURE THE SPECIMEN GAB BROKE. THE SURGOEN RETRIEVED THE SPECIMEN BUT A PORTION OF THE ENDOCATCH BAG COULD NOT BE LOCATED. THE ABDOMEN WAS IRRIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCATCH GOLD 10MM SPECIMEN POUCH DISPOSABLE SPECIMEN RETRIEVAL SYSTEM GCJ PONSE - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention