BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1924929 · Received December 8, 2010

    Report

    Report Number
    2647580-2010-00934
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 9, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: RESECTION. ACCORDING TO THE REPORTER: THE INSTRUMENT CUT THE TISSUE BUT DID NOT STAPLE IT. THE STAPLER WAS PROPERLY ASSEMBLED BUT THE STAPLES WERE NOT FULLY PLACED. THE PROCEDURE WAS COMPLETED USING MANUAL SUTURE. OPERATIVE TIME WAS DELAYED MORE THAN THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE STAPLER GDW USSC PUERTO RICO P0D0091H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other