BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES* EEA* ORVIL 21MM DEVICE

    MDR report key: 3212763 · Received July 1, 2013

    Report

    Report Number
    1219930-2013-00497
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 24, 2013
    Manufacturer
    COVIDIN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ANVIL WAS LEFT INSIDE THE PT. RE-OPERATION BECAUSE ORVIL WAS LEFT INSIDE STOMACH POUCH. ANVIL FELL INTO THE PT'S CAVITY. DEVICE FRAGMENT WAS LEFT IN THE PT BUT WAS LATER RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299846 DST SERIES* EEA* ORVIL 21MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other