BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTACT SEPTAL STAPLER

    MDR report key: 2661146 · Received July 13, 2012

    Report

    Report Number
    3007134070-2012-00002
    Event Type
    Injury
    Date Received
    July 13, 2012
    Date of Event
    June 20, 2012
    Report Date
    June 22, 2012
    Manufacturer
    ENTRIGUE SURGICAL INC.
    Product Code
    GDW
    PMA / PMN Number
    K082750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ENDOSCOPICALLY CONDUCTED A NASAL SEPTOPLASTY SURGERY ON (B)(6) 2012. USING THE ENTACT SEPTAL STAPLER, ALL EIGHT (8) (6 ANTERIOR AND 2 POSTERIOR) RESORBABLE STAPLE IMPLANTS WERE PLACED INTO THE MUCOSAL TISSUE ON ONE SIDE 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 EXPERIENCED A SEPTAL HEMATOMA AND WAS TAKEN BACK TO THE OPERATING ROOM WHERE THE EIGHT (8) RESORBABLE STAPLE IMPLANTS WERE REMOVED FROM THE PT. THE SEPTAL HEMATOMA WAS DRAINED AND THE SURGEON USED SUTURES TO COAPT THE MUCOSAL FLAPS AND COMPLETE THE CASE. ACCORDING TO THE ENTRIGUE SURGICAL SALES REP, THE PHYSICIAN EXPLAINED THE PT IS DOING WELL AND NO COMPLICATIONS HAVE BEEN OBSERVED DURING SUBSEQUENT 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. 203020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention