BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 30-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1771933 · Received July 21, 2010

    Report

    Report Number
    2647580-2010-00638
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 21, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DURING FIRING HANDLE LOCKED DOWN. ADDITIONAL RESECTION OF TISSUE WAS DONE IN ORDER TO REMOVE THE DEVICE. THEN, IT WAS NOTICED THE STAPLING WAS NOT DONE AT ALL. ADDITIONAL MANUAL SUTURING WAS DONE. NO BLEEDING. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PATIENT INFO AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 30-4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P8L0899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S