BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 21MM SINGLE USE STAPLER WITH

    MDR report key: 2001715 · Received February 22, 2011

    Report

    Report Number
    2647580-2011-00124
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE STAPLERS DID NOT FORM OR HOLD THE TISSUE DURING THE CASE. LOOSE STAPLES WERE REMOVED AND THE DOCTOR OBTAINED ANOTHER DEVICE TO FINISH THE CASE. THE INTRA-OPERATIVE BLUE DYE TEST FAILED INDICATING A LEAK, SO THE SURGEON CONVERTED TO A LINEAR ANASTOMOSIS. ADD'L TISSUE WAS RESECTED BUT THE PROCEDURE WAS NOT EXTENDED BY MORE THAN THIRTY MINUTES. TO COMPLETE THE CASE, SURGEON USED A GIA 90 TAN LOAD TO CLOSE THE ENTEROTOMY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 21MM SINGLE USE STAPLER WITH DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other