BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 2980148 · Received February 22, 2013

    Report

    Report Number
    9612501-2013-00013
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 29, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHILE REMOVING THE DEVICE FROM THE PACKAGING, THE POUCH FELL OFF OF THE HANDLE. THE DEVICE WAS NOT USED ON THE PT. THE POUCH AND DRAW STRING RING ARE MISSING FROM THE HANDLE AND WERE NOT RETAINED. ONE OF THE BLACK PLASTIC TIPS ON THE SPECIMEN POUCH RETAINING RING IS ALSO MISSING. THERE WAS NO OTHER DAMAGE NOTED ON THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78633 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL PRODU GCI COVIDIEN J2H0082XM

    Patients

    Seq Age Sex Outcome Treatment
    1