BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3021637 · Received March 15, 2013

    Report

    Report Number
    2647580-2013-00150
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC P
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP SIGMOID. ACCORDING TO THE REPORTER: STAPLER WAS FIRED WITHOUT INCIDENT. FIRST FIRING SEEMED FINE AND TISSUE DID NOT APPEAR UNUSUALLY THICK; COMPLETE VISUALIZATION OF THE GREEN BAR PRIOR TO FIRING WAS EASILY ACCOMPLISHED. NO REINFORCEMENT MATERIAL WAS USED. UPON INSPECTION OF THE DONUTS, PROXIMAL DONUT WAS THICK, BUT INCOMPLETE. THE SURGEON VISUALLY INSPECTED THE ANASTOMOSIS AND MUCOSA WAS PRESENT OUTSIDE THE STAPLE LINE. A LEAK TEST WAS PERFORMED AND NO LEAK WAS DETECTED. THE ANASTOMOSIS WAS RESECTED AND A NEW ANASTOMOSIS CREATED WITH ANOTHER EEA31 WITHOUT INCIDENT. THERE APPEARS TO BE AN AREA IN THE STAPLE LINE OF THE ORIGINAL ANASTOMOSIS THAT MAY NOT HAVE CUT COMPLETELY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110823 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P P1M0735X

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other