BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 2982832 · Received January 31, 2013

    Report

    Report Number
    9612501-2013-00011
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 4, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: NOT REPORTED. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE LOOP OF THE DEVICE BROKE WHEN THE SURGEON TRIED TO CLOSE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42016 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCI COVIDIEN J2F0278XM

    Patients

    Seq Age Sex Outcome Treatment
    1