BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 4210355 · Received October 29, 2014

    Report

    Report Number
    9612501-2014-00382
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PROCTECTOMY.ACCORDING TO THE REPORTER: THE DEVICE WAS USED, THE BAG CLOSED ON THE SPECIMEN, THE HANDLE WAS REMOVED AND THE METAL RING STAYED INSIDE THE PATIENT. POST PROCEDURE THE RING WAS RETRIEVED BUT THE O-RING WAS MISSING. THE O-RING DEVICE FRAGMENT WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692376 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCI COVIDIEN 173050G

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other