BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 21MM SINGLE USE STAPLER WITH 3.5MM

    MDR report key: 3001344 · Received March 6, 2013

    Report

    Report Number
    2647580-2013-00143
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER FIRING, THE DEVICE COULD NOT BE REMOVED. THE SURGEON HAD TO EXCISE THE TISSUE TO REMOVE THE DEVICE. DOUGHNUT RING ON ORAL SIDE WAS MADE, BUT THE ANAL SIDE TISSUE WAS NOT CUT COMPLETELY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. NO REINFORCEMENT MATERIAL WAS USED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95211 EEA 21MM SINGLE USE STAPLER WITH 3.5MM DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1J0519H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other