BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCATCH GOLD 10MM SPECIMEN POUCH

    MDR report key: 1073693 · Received July 3, 2008

    Report

    Report Number
    9612501-2008-00033
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 9, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: SURGEON INDICATED THAT THE BAG BROKE AWAY FROM THE METAL RING PREMATURELY AND THAT THE DEVICE COULD NOT BE RETRACTED ONCE THE SPECIMEN WAS IN THE BAG. NO PT INJURY WAS REPORTED. PROCEDURE: LAP CHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCATCH GOLD 10MM SPECIMEN POUCH SURGICAL SPECIMEN POUCH GCJ SANTO DOMINGO - USS

    Patients

    Seq Age Sex Outcome Treatment
    1