BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH II 15MM SPECIMEN POUCH

    MDR report key: 1830497 · Received September 2, 2010

    Report

    Report Number
    9612501-2010-00042
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 18, 2010
    Manufacturer
    DAVIS AND GECK CARIBE, LTD.
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: TUMOR REMOVAL. ACCORDING TO THE REPORTER: THE BAG BROKE WHILE TRYING TO RETRIEVE THE SPECIMEN OUT OF THE ABDOMINAL CAVITY. NO ILL EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH II 15MM SPECIMEN POUCH DISPOSABLE SURGICAL ACCESSORY GCI DAVIS AND GECK CARIBE, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1