BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 33MM SINGLE-USE STAPLER

    MDR report key: 2903621 · Received January 3, 2013

    Report

    Report Number
    2647580-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: RECTUM RESECTION. ACCORDING TO THE REPORTER: RESECTION PERFORMED AT ABOUT 10 CM. THE PT HAD AN INSUFFICIENCY FOUR DAYS FOLLOWING SURGERY AND HAD TO BE REVISED/REOPERATED. A PROTECTIVE ILEOSTOMY WAS PERFORMED. INTRA-OPERATIVELY NO ABNORMALITY WAS DETECTED; THE INSTRUMENT FUNCTIONED PROPERLY. THE CLIP SEAM WAS FOUND TO BE GOOD INTRA-OPERATIVELY AND WAS ALSO CLOSED. AN INTRAOPERATIVE LEAK TEST DONE AT APPLICATION. THE ANASTOMOSIS WAS SOLID INTRA-OPERATIVE. NO REINFORCEMENT MATERIAL WAS USED. NO BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3527 EEA 33MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2F0412H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other