BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 30-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1900224 · Received November 10, 2010

    Report

    Report Number
    2647580-2010-00861
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 14, 2010
    Manufacturer
    USSC PUERTO RICO
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY BY THORACOTOMY RIGHT UPPER LOBE BRONCHUS BRONCHOPLASTY. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE TA30 WAS BEING USED TO STAPLE THE BRONCHUS - STAPLER ENGAGED BUT DID NOT FIRE. THE SURGEON, ASSUMING THAT THE STAPLE LINE HAD BEEN COMPLETED, CUT THE BRONCHUS ALONG THE SIDE OF THE STAPLER. WHEN THE STAPLER WAS REMOVED, NO STAPLES HAD BEEN FIRED. SURGEON ATTEMPTED TO FIRE AGAIN AFTER STAPLER WAS REMOVED FROM PT, AND STAPLER DID FIRE. THE BRONCHUS HAD TO BE OVERSEWN, (BRONCHUS/BRONCHOPLASTY) SUTURED BY SURGEON, INCREASING OPERATIVE TIME BY 90 MINUTES. THE SAMPLE IS BEING SENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 30-4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0G0019

    Patients

    Seq Age Sex Outcome Treatment
    1