BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3170074 · Received June 5, 2013

    Report

    Report Number
    2647580-2013-00285
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SMALL BOWEL RESECTION. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE STAPLER WAS POSITIONED AROUND THE TISSUE AND FIRED IN A NORMAL FASHION. UPON INSPECTION OF THE STAPLE LINE, IT WAS NOTICED THAT ALTHOUGH THE FIRST PORTION OF THE STAPLE LINE WAS INTACT, THE LAST 50MM WAS WIDE OPEN WITH NO STAPLES IN PLACE. THE RESECTION HAD TO BE RE-DONE. NOTHING FELL IN THE PATIENT'S CAVITY. ADD'L RECTUM WAS LOST DUE TO THE FAILED STAPLE LINE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE LOT NUMBER OF THE DEVICE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249470 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1