BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 45-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1219504 · Received November 3, 2008

    Report

    Report Number
    2647580-2008-00620
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 23, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR INITIAL REPORT SUBMITTED: 11/03/2008.

    Description of Event or Problem · 1

    PROCEDURE: HIGH ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED ON THE RECTUM AND AN ANASTOMOSIS WAS PERFORMED WITH AN EEA. THE SURGEON CONFIRMED A STAPLES LINE LEAK AT THE SITE WHEN THE TA STAPLER WAS USED. THE ISSUE WAS RESOLVED BY DOING ADDITIONAL SUTURING. A TEMPORARY STOMA WAS PLACED AS A PRECAUTION. NO FURTHER ISSUE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 45-3.5 SINGLE USE RELOADABLE STAPLER STAPLING DEVICE GDW PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention