BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USER STAPLER

    MDR report key: 3170193 · Received June 7, 2013

    Report

    Report Number
    2647580-2013-00327
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLORECTAL. ACCORDING TO THE REPORTER: DURING ANASTOMOSIS, THE ANVIL DISCONNECTED AND STAYED STUCK INSIDE THE PATIENT'S COLON. THE SURGEON HAD TO DO ANOTHER RESECTION WITH A SECOND INSTRUMENT IN ORDER TO BE ABLE TO REMOVE THE ANVIL. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253619 EEA 28MM SINGLE-USER STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P2D0391X

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other