BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTACT SEPTAL STAPLER

    MDR report key: 2785745 · Received October 10, 2012

    Report

    Report Number
    3007134070-2012-00003
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Product Code
    OLL
    PMA / PMN Number
    K082750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENTRIGUE SURGICAL SALES REPRESENTATIVE ((B)(4)) REPORTED ON (B)(4) 2012 THAT AN ADVERSE EVENT OCCURRED FOLLOWING A CASE WITH DR (B)(6).

    Description of Event or Problem · 1

    THE PHYSICIAN ENDOSCOPICALLY CONDUCTED A NASAL SEPTOPLASTY SURGERY ON (B)(6) 2012. THE ENTACT SEPTAL STAPLER IS SUPPLIED PRE-LOADED WITH EIGHT RESORBABLE STAPLE IMPLANTS. USING THE ENTACT SEPTAL STAPLER, ALL EIGHT IMPLANTS WERE PLACED INTO THE MUCOSAL TISSUE ON BOTH SIDES OF THE PT'S SEPTUM FOR COAPTATION. ACCORDING TO THE PHYSICIAN, A VISUAL VERIFICATION (VIA ENDOSCOPE) WAS PERFORMED UPON IMPLANTATION OF THE RESORBABLE IMPLANTS AND SUCCESSFUL INSERTION OF ALL EIGHT STAPLES WAS CONFIRMED. THERE WERE NO DELAYS OR ISSUES WITH THE ENTACT SEPTAL STAPLER DURING THE SURGERY. THE PT WAS RELEASED AFTER THE SURGERY WITHOUT ANY ISSUES. THE PT RETURNED TO THE CLINIC SEVERAL DAYS POST-OP WITH NASAL OBSTRUCTION. ACCORDING TO THE PHYSICIAN, THE PT EXPERIENCED A SEPTAL HEMATOMA THAT REQUIRED AN INCISION TO DRAIN THE HEMATOMA AND A NEEDLE/SYRINGE WAS USED TO DRAIN THE HEMATOMA. ACCORDING TO THE PHYSICIAN, NO FURTHER COMPLICATIONS HAVE BEEN OBSERVED DURING SUBSEQUENT POST-OPERATIVE VISITS AND THE PT HAS RECOVERED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTACT SEPTAL STAPLER SEPTAL STAPLER / ABSORBABLE STAPLES OLL ENTRIGUE SURGICAL, INC. 205018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYNAERO HEMOSTATIC GEL