BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 2061218 · Received April 5, 2011

    Report

    Report Number
    2647580-2011-00231
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 15, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: RECTO-ENDOMETRIOSIS. ACCORDING TO THE REPORTER: ONLY TISSUE RESECTION WAS ACTUATED, AND NOT THE SUTURE. IT WAS NECESSARY TO PERFORM A NEW RECTO RESECTION WITH ILEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO U7J73

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention