BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTACT SEPTAL STAPLER

    MDR report key: 2067943 · Received April 20, 2011

    Report

    Report Number
    3007134070-2011-00001
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ENTRIGUE SURGICAL INC.
    Product Code
    GDW
    PMA / PMN Number
    K082750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN CONDUCTED NASAL SEPTOPLASTY SURGERY ON (B)(6) 2011. USING THE ENTACT SEPTAL STAPLER, 3 OUT OF 8 RESORBABLE STAPLE IMPLANTS WERE PLACED INTO THE MUCOSAL TISSUE FOR COAPTATION. THE PT WAS RELEASED AFTER THE SURGERY WITHOUT ISSUE. ON (B)(6) 2011, THE PT RETURNED TO THE PHYSICIAN WITH FACIAL PAIN, SWELLING, FEVER AND ERYTHEMA OF THE SEPTUM. THE PT WAS TAKEN BACK TO THE OPERATING ROOM WHERE AN INCISION AND DRAINAGE WAS PERFORMED BY THE PHYSICIAN TO RELIEVE THE PRESSURE AND SWELLING. THE PT WAS PLACED ON ANTIBIOTICS AND A SPECIMEN OF THE FLUID WAS SENT FOR MICROBIAL ANALYSIS. THE PT IMMEDIATELY FELT BETTER AFTER THE PROCEDURE AND WAS DOING WELL ON POST-OPERATIVE VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTACT SEPTAL STAPLER SEPTAL STAPLER/ABSORBABLE STAPLES GDW ENTRIGUE SURGICAL INC. 101037

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention