BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 3172857 · Received May 30, 2013

    Report

    Report Number
    9612501-2013-00058
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    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

    ACCORDING TO THE REPORTER: THE BAD BROKE INSIDE THE PT. ANOTHER DEVICE WAS USED WITHOUT FURTHER CONSEQUENCE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238724 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMENT RETRIEVAL PRODU GCJ COVIDIEN J2J0073XM

    Patients

    Seq Age Sex Outcome Treatment
    1