BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTACT SEPTAL STAPLER

    MDR report key: 1545607 · Received November 24, 2009

    Report

    Report Number
    3007134070-2009-00001
    Event Type
    Injury
    Date Received
    November 24, 2009
    Date of Event
    October 27, 2009
    Report Date
    November 4, 2009
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Product Code
    GDW
    PMA / PMN Number
    K082750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TO UNDERGO A SEPTOPLASTY FOR TREATMENT OF SLEEP APNEA. AFTER THE SEPTOPLASTY WAS COMPLETED, THE ENTACT SEPTAL STAPLER WAS UTILIZED TO COAPT THE MUCOPERICHONDRIAL FLAPS. THE PHYSICIAN BELIEVED HE DEPLOYED 7 STAPLES, BUT COULD NOT VISUALIZE STAPLES DUE TO SEPTAL EDEMA. THREE HOURS POST OPERATION, THE PHYSICIAN NOTED THAT THE PATIENT'S "SEPTUM WAS WIDE." PATIENT'S O2 STATS WERE MONITORED CLOSELY AND FOUND TO BE OKAY. PATIENT SEPTAL HEMATOMA WAS DRAINED IN THE OR THE NEXT DAY. PHYSICIAN NOTED, "THERE WAS NO EVIDENCE OF ANY STAPLES PRESENT AT ALL. WHEN I TOLD THE REP I DID NOT SEE ANY STAPLES, HE SAID THEY WERE CLEAR AND THAT WAS COMMON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTACT SEPTAL STAPLER IMPLANTABLE STAPLE GDW ENTRIGUE SURGICAL, INC. 601-00100 903027

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention