BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA PREMIUM 90-4.8 TITANIUM DLU

    MDR report key: 2945782 · Received February 1, 2013

    Report

    Report Number
    2647580-2013-00057
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K855047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: RESECTION. ACCORDING TO THE REPORTER: THE STAPLER WAS FIRED, THE INTESTINE WAS NOT CLOSED, THE STAPLES REMAINED OPENED. TWO CENTIMETERS OF INTESTINE HAD TO BE REMOVED DUE TO TISSUE DAMAGE. THE DURATION OF PROCEDURE WAS PROLONGED BY 35MIN THE DEVICE WAS DISPOSED OF BY MISTAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43741 TA PREMIUM 90-4.8 TITANIUM DLU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P2AD479X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other