BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CATCH II 15 MM

    MDR report key: 5011267 · Received August 12, 2015

    Report

    Report Number
    MW5055477
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 12, 2015
    Manufacturer
    COVIDEN (DISTRIBUTED BY CARDINAL HEALTH 1-800-964-5227) 1-800-962-9888
    Product Code
    GCI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING ROBOTIC SURGERY FOR A LUNG RESECTION ON (B)(6) 2015. DURING THE USE OF THE ENDO CATCH, PART OF THE BOTTOM OF THE PLASTIC BAG SEPARATED AWAY. TWO PIECES OF THE BAG WERE RETRIEVED. THE BAG IS STRETCHED OUT AND IT IS IMPOSSIBLE TO FIT THE PIECES BACK TOGETHER TO SAY WITH CERTAINTY IF ALL PIECES WERE RETRIEVED. THE SURGEON DID A THOROUGH CHECK AND FEELS CONFIDENT THAT ALL PIECES WERE RETRIEVED. THIS BAG IS NON-X-RAY DETECTABLE. IT IS A DISPOSABLE PIECE OF EQUIPMENT-1X USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529674 ENDO CATCH II 15 MM SINGLE USE SPECIMEN RETRIVAL POUCH GCI COVIDEN (DISTRIBUTED BY CARDINAL HEALTH 1-800-964-5227) 1-800-962-9888 173049 J5B0519X

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention