BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1001043 · Received February 20, 2008

    Report

    Report Number
    1219930-2008-00160
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 25, 2008
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP RECTUM. ACCORDING TO THE REPORTER: AFTER ATTACHING THE ANVIL AND THE DEVICE, THE WINGNUT WAS ROTATED TO CLOSE UNTIL THE GREEN MARK BECAME VISIBLE. THE SURGEON THEN NOTICED A KINK OF THE BOWEL, SO THE WINGNUT WAS ROTATED TO OPEN THE DEVICE, AND THE ANVIL TILTED. TO REMOVE THE ANVIL AND THE DEVICE, THE TISSUE WAS RESECTED, AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO BLEEDING OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN-USS U7H62

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention