BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 3131556 · Received May 17, 2013

    Report

    Report Number
    9612501-2013-00050
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SPECIMEN BAG RIPPED AWAY FROM THE RING AT A POINT UNDERNEATH THE PULL STRING SEPARATING THE BAG FROM THE STRING AND RING OF THE DEVICE. THE BAG WAS EXTRACTED, NO DEVICE FRAGMENT OR COMPONENT WAS LEFT IN THE PATIENT. 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
    219988 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL GCI COVIDIEN J2K0143XM

    Patients

    Seq Age Sex Outcome Treatment
    1