BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 3131557 · Received May 17, 2013

    Report

    Report Number
    9612501-2013-00048
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: WHILE RETRIEVING THE SPECIMEN A PORTION OF PLASTIC THAT IS DESIGNED TO REMAIN ATTACHED TO THE METAL RING LOOSE AND FELL INSIDE THE PATIENT. THE PIECE OF PLASTIC WAS RETRIEVED WITHOUT ANY TISSUE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219828 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL GCI COVIDIEN J2L0009X

    Patients

    Seq Age Sex Outcome Treatment
    1