BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCATCH GOLD 10MM SPECIMEN POUCH

    MDR report key: 1181981 · Received September 26, 2008

    Report

    Report Number
    9612501-2008-00052
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 16, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING REMOVAL OF GALL BLADDER, THE BAG TORE APART FROM THE RING. THE SECOND BAD USED DID THE SAME THING, BUT THE ISSUE WAS RESOLVED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCATCH GOLD 10MM SPECIMEN POUCH SURGICAL SPECIMEN POUCH GCJ SANTO DOMINGO - USS J8E0035

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR