BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEROSAFUSE®

    MDR report key: 23563258 · Received November 14, 2025

    Report

    Report Number
    1721504-2025-00599
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    ODE
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT UPON FULL INSERTION OF THE DEVICE INTO THE ANATOMY, WITH RETROFLEXION OF THE ENDOSCOPE IT WAS NOTICED THAT THE HELICAL RETRACTOR WAS BENT AND HAD MUCOSAL TISSUE WITHIN THE COILS. BLEEDING WAS OBSERVED AT THE EGJ ANATOMY. THE DEVICE WAS REMOVED FROM THE PATIENT, AND VISUAL INSPECTION OF THE ESOPHAGUS WAS CONDUCTED USING AN UPPER GI ENDOSCOPE. AN APPROXIMATE 15 CM TEAR IN THE ESOPHAGEAL MUCOSA WAS OBSERVED. THE TIF 2.0 PORTION OF THE PROCEDURE WAS ABORTED, ENDOSCOPIC CLIPS WERE EMPLOYED TO CLOSE THE MUCOSAL TEARING, AND THE PROCEDURE WAS CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2714423 SEROSAFUSE® ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE MERIT MEDICAL SYSTEMS, INC. H3262211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention