BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEROSAFUSE IMPLANTABLE FASTENER KIT

    MDR report key: 22810243 · Received August 14, 2025

    Report

    Report Number
    1721504-2025-00257
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 14, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    EGS
    UDI-DI
    00810275014011
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE CANNOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES A PATIENT ENTERED THE ER 6 DAYS POST-OP ON (B)(6) 2025 WITH ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. CT SCAN SAME DAY SHOWED APPROXIMATELY 2X2CM COLLECTION OF AIR AND ORAL CONTRAST PROXIMAL TO GEJ IN ABDOMEN, THEY NOTED CONCERN FOR CONTAINED ESOPHAGEAL PERFORATION. THE PATIENT WAS PLACED ON PAIN MEDS, ABX AND ANTIFUNGAL. THE PATIENT REQUIRED 3 UNITS OF BLOOD TRANSFUSED. THEY PERFORMED EGD ON (B)(6), FOUND BLEEDING IN STOMACH, CLOSE TO GEJ THOUGH EXACT SOURCE OF BLEEDING WAS INDETERMINATE. ENDOCLOT POWDER WAS SPREAD OVER GEFV. STENT WAS PLACED ACROSS GEJ. SUBSEQUENT CT SCAN ORDERED SHOWED 2.6X2.3CM COLLECTION OF AIR AND ORAL CONTRAST IN ABDOMEN PROXIMAL TO GEJ IN ABDOMEN, BLEEDING IN THE ANTERIOR LESSER CURVATURE OF THE STOMACH, AND NOTED A SMALL PLEURAL EFFUSION. 2ND EGD SHOWED STENT HAD MIGRATED AND IT WAS SUBSEQUENTLY REMOVED. CAUTERY WAS USED ON THE LIP OF THE GEFV AT APPROXIMATELY THE 5 O'CLOCK LOCATION WHERE BLEEDING WAS NOTED, CLIP WAS PLACED IN THIS LOCATION. THEY HAVE CHARACTERIZED THIS AS A LEAK AT THE GEJ - THEORIZING THE SMALL LEAK WAS ALONG THE PATH OF A SEROSA FUSE FASTENER - AND NOT DUE TO AN ESOPHAGEAL PERFORATION. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788699 SEROSAFUSE IMPLANTABLE FASTENER KIT HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS MERIT MEDICAL SYSTEMS INC. 00810275014011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention