BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3940772 · Received July 2, 2014

    Report

    Report Number
    2647580-2014-00498
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    February 27, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ANTERIOR RESECTION. ACCORDING TO THE REPORTER: EEA31 WAS PLACED AND FIRED PROPERLY. PULLED OUT OF THE CAVITY WITHOUT ANY DIFFICULTIES. AFTER INSPECTING THE DONUTS, IT WAS NOTICED THAT DISTAL DONUT WAS FULL, BUT THE PROXIMAL WAS NOT COMPLETE. AFTER A LEAK TEST, THE LEAKAGE WAS DISCOVERED ABOVE THE STAPLE LINE ON THE POSTERIOR SIDE. THAT PIECE OF TISSUE HAD TO BE REMOVED (WITH COMPETITOR'S DEVICE) AND THE ANASTOMOSIS WAS RE-DONE WITH ANOTHER COMPETITOR'S DEVICE. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. AN ILEOSTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385319 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY USSC PUERTO RICO, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other