BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INT 1

    MDR report key: 1894228 · Received November 3, 2010

    Report

    Report Number
    9612501-2010-00047
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    DAVIS AND GECK CARIBE, LTD.
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: OOPHORECTOMY. ACCORDING TO THE REPORTER: THE DEVICE'S BAG RIPPED AS THE SURGEON WAS PULLING THE SPECIMEN THROUGH THE FASCIAL AND SKIN INCISION. THE SPECIMEN DISLODGED FROM THE BAG AND FELL BACK INTO THE ABDOMINAL CAVITY. ANOTHER DEVICE WAS USED TO FINISH THE CASE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INT 1 DISPOSABLE SURGICAL ACCESSORY GCI DAVIS AND GECK CARIBE, LTD. J0H0037

    Patients

    Seq Age Sex Outcome Treatment
    1