BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1081257 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00552
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    March 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: THE STAPLER DID NOT COMPLETELY CUT, AND THE SURGEON HAD TO DO A MANUAL PROCEDURE TO FINISH THE CASE. NO OTHER INFO HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7G44

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention