BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 3060517 · Received March 26, 2013

    Report

    Report Number
    9612501-2013-00032
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: UPON DEPLOYMENT OF BAG VIA THE WHITE RING, THE CONCENTRIC METAL RING OPENED UP WITHIN THE ABDOMEN AS INTENDED. THE GALLBLADDER WAS PLACED INTO THE BAG, AND THE GOLD RING WAS PULLED TO CINCH THE BAG. THE SUTURE WAS CUT FROM THE SHAFT OF THE BAG, AND THE WHITE RING WAS PULLED BACK TO RETRACT THE METAL RING BACK INTO THE SHAFT OF THE DEVICE, PRIOR TO REMOVAL FROM THE ABDOMEN. AT THIS POINT, THE RING DID NOT RETRACT, BUT INSTEAD, FELL FORWARD OUT OF THE BLACK SHAFT OF THE DEVICE AND INTO THE ABDOMEN. A LAPAROSCOPIC GRASPER HAD TO BE USED TO PULL THE METAL RING, AND ATTACHED WHITE SHAFT THROUGH THE TROCAR. 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
    123165 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL GCI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1