BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 30-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2922503 · Received January 14, 2013

    Report

    Report Number
    2647580-2013-00038
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    October 18, 2012
    Report Date
    December 15, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: THE RETRACTION PIN DID NOT RETRACT BACK AFTER FIRING THE TA AND CAUSED A TEAR INTRA OPERATIVELY DURING A LOBECTOMY. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO ADD'L INFO WILL BE SUPPLIED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20067 TA 30-4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1J0056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other