BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1900062 · Received November 9, 2010

    Report

    Report Number
    2647580-2010-00885
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 12, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOWER ANTERIOR RESECTION WITH END-END ANASTOMOSIS. ACCORDING TO THE REPORTER: THE PATIENT WENT TO SURGERY SUFFERING WITH PERITONITIS. DURING ACTIVATION OF THE INSTRUMENT, THE SURGEON THOUGHT THE INSTRUMENT WAS CLOSING TOO EASILY. THE INSTRUMENT WAS ACTIVATED, AND THE RESULTING DISTAL DONUT WAS VERY THIN. THE SURGEON DID AN AIR LEAK TEST AND A LEAK WAS PRESENT. AN ILEOSTOMY HAD TO BE PERFORMED. THE PATIENT CONDITION WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0F0340H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention