BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 45-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1924857 · Received December 8, 2010

    Report

    Report Number
    2647580-2010-00950
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DEVICE FIRED AND NO STAPLES WERE DISPENSED FROM THE DEVICE. DOCTOR HAD TO HANDSEW TO CORRECT THE AREA. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS EXTENDED BY MORE THAN 2 HOURS. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 45-3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O