BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 90 - 4.8 SINGLE USE RELOADABLE

    MDR report key: 1211575 · Received October 22, 2008

    Report

    Report Number
    2647580-2008-00610
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 14, 2008
    Report Date
    October 16, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR INITIAL REPORT SUBMITTED: 10/22/2008.

    Description of Event or Problem · 1

    PROCEDURE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE STAPLER DID NOT FORM THE B SHAPE. MINIMAL BLEEDING (LESS THAN 250) WAS REPORTED AND THERE WAS TISSUE DAMAGE. THE SURGERY WAS COMPLETED WITH NO FURTHER PATIENT ISSUE OR DEVICE ISSUE REPORTED. PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 90 - 4.8 SINGLE USE RELOADABLE SURGICAL STAPLER GDW PONCE - USS P8C0453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention