BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH II 15MM SPECIMEN POUCH

    MDR report key: 736330 · Received June 24, 2005

    Report

    Report Number
    2647580-2005-00347
    Event Type
    Malfunction
    Date Received
    June 24, 2005
    Report Date
    May 25, 2005
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    6/23/2005 - INITITAL REPORT SENT TO THE FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY THE SPECIMEN POUCH DISENGAGED FROM THE INSTRUMENT WHICH THE SURGEON WAS ABLE TO RETRIEVE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH II 15MM SPECIMEN POUCH DISPOSABLE SPECIMEN RETRIEVAL SYSTEM GCJ PONCE - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN