BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1201569 · Received October 17, 2008

    Report

    Report Number
    1219930-2008-00748
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 10/16/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: IT WAS DIFFICULT TO RELEASE THE HEAD OF THE DEVICE. WHEN THE INSTRUMENT WAS REMOVED, A SECOND ONE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7M08H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention