BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 2861748 · Received November 26, 2012

    Report

    Report Number
    2647580-2012-00747
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 31, 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
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ACCORDING TO THE REPORTER: THE STAPLES DIDN'T CLOSE PERFECTLY DURING THE OPERATION LEADING TO LEAKS AND A COMPLETE DISRUPTION OF THE STAPLES AND SEPARATION OF THE TWO SIDES. RE-OPERATION FOR THE PATIENT WITH COLOSTOMY AFTER FIFTH DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2C0794X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention