BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTACT SEPTAL STAPLER

    MDR report key: 2644344 · Received July 2, 2012

    Report

    Report Number
    3007134070-2012-00001
    Event Type
    Injury
    Date Received
    July 2, 2012
    Date of Event
    April 12, 2012
    Report Date
    June 4, 2012
    Manufacturer
    ENTRIGUE SURGICAL INC.
    Product Code
    GDW
    PMA / PMN Number
    K082750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN CONDUCTED A NASAL SEPTOPLASTY SURGERY ON (B)(6) 2012 UNDER DIRECT VISUALIZATION. USING THE ENTACT SEPTAL STAPLER, THE RESORBABLE STAPLE IMPLANTS WERE PLACED INTO THE MUCOSAL TISSUE ON BOTH SIDES OF THE SEPTUM FOR COAPTATION. THE PHYSICIAN MENTIONED A VISUAL VERIFICATION WAS PERFORMED UPON IMPLANTATION OF THE RESORBABLE IMPLANTS. THERE WAS NO DELAYS OR ISSUES WITH THE ENTACT SEPTAL STAPLER DURING THE SURGERY. THE PT WAS RELEASED AFTER THE SURGERY WITHOUT ANY ISSUES. ON (B)(6) 2012, SEVEN DAYS POST-OP, THE PT WAS TAKEN BACK TO THE OPERATING ROOM WHERE AN INCISION AND DRAINAGE WAS PERFORMED BY THE PHYSICIAN TO DRAIN A SEPTAL HEMATOMA. ACCORDING TO THE PHYSICIAN, THE PT IS DOING WELL AND NO COMPLICATIONS HAVE BEEN OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTACT SEPTAL STAPLER SEPTAL STAPLER / ABSORBABLE STAPLES GDW ENTRIGUE SURGICAL INC. 201086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention