BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEON ENDOSCOPIC STAPLER

    MDR report key: 17626071 · Received August 25, 2023

    Report

    Report Number
    3012998149-2023-00004
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    LEXINGTON MEDICAL INC.
    Product Code
    GDW
    UDI-DI
    00851574008943
    PMA / PMN Number
    222210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATION, THE LEVEL ONE ROOT CAUSE FOR BLEEDING WAS THAT THE SURGEON HAD FIRED THE RELOAD WITH A HEM-O-LOCK IN THE RELOAD JAWS, RESULTING IN MULTIPLE MALFORMED STAPLES. FIRING A RELOAD OVER AN OBSTRUCTION IS KNOWN TO RESULT IN STAPLE MALFORMATION AND THEREFORE POOR HEMOSTATIC PERFORMANCE. THE IFU USED FOR THIS REGION IS MOST LIKELY THE SPANISH LANGUAGE VERSION OF 900298. IN THE SPANISH VERSION OF 900298 REV-T (THE MOST RECENT REVISION THAT WAS APPROVED BY COLOMBIAN AUTHORITIES AT TIME OF THE EVENT), WARNING #5 ON PAGE 7 INDICATES THAT FIRING OVER AN OBSTRUCTION CAN RESULT IN INCORRECTLY FORMED STAPLES. THE LEVEL TWO ROOT CAUSE IS THEREFORE USER ERROR.

    Description of Event or Problem · 0

    FIVE 45 GREY CURVED RELOADS AND ONE 30 WHITE CURVED RELOAD WERE USED FOR A LOBECTOMY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE THE SURGEON FIRED THE RELOAD TO SEAL AN ARTERY, THE STAPLE LINE DID NOT FULLY SEAL THE ARTERY AND THE PATIENT BLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803237 AEON ENDOSCOPIC STAPLER AEON ENDOSCOPIC STAPLER GDW LEXINGTON MEDICAL INC. AESC45G 22BR541 00851574008943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED| AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED| AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED| AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED| ASR30WC AEON ENDOSCOPIC STAPLER 2.5MM/30MM CURVED