BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1062594 · Received June 17, 2008

    Report

    Report Number
    1219930-2008-00461
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 4, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 06/17/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP SIGMOID COLECTOMY. ACCORDING TO THE REPORTER: NO INTRA-OPERATIVE COMPLICATIONS OR ABNORMALITIES WERE NOTED. THE ANASTOMOSIS WAS AIR TESTED AND THE DONUTS WERE NORMAL. THREE DAYS POST-OPERATIVELY, A LEAK WAS FOUND BUT THE ORIGIN COULD NOT BE ESTABLISHED. THE PATIENT WAS RE-OPERATED AND A TEMPORARY COLOSTOMY WAS SET. IT IS REPORTED THAT THE ANASTOMOSIS WAS VERY LOW IN A NARROW PELVIS. THE PATIENT IS IN WELL CURRENT CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R