BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 45-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3131432 · Received May 9, 2013

    Report

    Report Number
    2647580-2013-00249
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ANTERIOR RESECTION. ACCORDING TO THE REPORTER. AFTER A LAP MOBILIZATION DURING A LAP ANTERIOR RESECTION, THE SURGEON APPLIED THE TA STAPLER THROUGH A PFANNENSTIEL, LOW DOWN IN THE RECTUM, POSITIONED IT, CLOSED AND FIRED. NO STAPLES WERE DELIVERED BUT THE INCIDENT RESULTED IN A FULL LAPAROTOMY AND AN UNANTICIPATED EXTENSION OF THE INCISION BY APPROXIMATELY FIVE INCHES. THE SURGEON SUTURED THE ANASTOMOSIS TO CORRECT THE CONDITION. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NO REINFORCEMENT MATERIAL WAS USED. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES PER ORIGINAL FTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204876 TA 45-4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P2K0275X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other