BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 3021556 · Received March 14, 2013

    Report

    Report Number
    1219930-2013-00188
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    COVIDEN, FORMERLY US
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE DST EEA 28-4.8 STAPLER WAS FIRED ON THE PATIENT'S SIGMOID COLON. ALL WAS WITHIN CORRECT STAPLING PARAMETERS. AFTER IT WAS FIRED THE STAPLER WAS REMOVED. IT WAS CHECKED FOR CONSISTENT DONUTS. THIS WAS CONFIRMED. WHEN THE SURGEON INSPECTED THE STAPLE LINE, THE ANASTOMOSIS FELL APART. THEY DESCRIBED THAT IT LOOKED LIKE ONLY HALF OF THE STAPLE-LINE FIRED STAPLES. THE OTHER HALF DID NOT. THEY RESOLVED THE ISSUE BY GIVING THE PATIENT AN UN-NEEDED TEMPORARY COLOSTOMY. THIS MAY BE ABLE TO BE REVERSED IN A FEW MONTHS. A TEMPORARY COLOSTOMY WAS DONE AS A RESULT OF THE STAPLER FAILURE, MAY BE ABLE TO REVERSE IT IN A FEW MONTHS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108508 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDEN, FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other