BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEROSAFUSE IMPLANTABLE FASTENER

    MDR report key: 11626877 · Received April 7, 2021

    Report

    Report Number
    11626877
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 23, 2021
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER SUCCESSFUL COMPLETION OF A LAPAROSCOPIC HIATAL HERNIA REPAIR, A TRANSORAL INCISIONLESS FUNDOPLICATION PROCEDURE WAS ATTEMPTED. WHILE THE TIF PROCEDURE WAS UNDERWAY, THE ENDOGASTRIC SOLUTIONS ESOPHYX DEVICE MISFIRED. THE ENDOSCOPE BECAME LODGED IN THE ESOPHYX DEVICE. THE ESOPHYX DEVICE AND ENDOSCOPE WERE EXTUBATED. BOTH INSTRUMENTS WERE EXTUBATED SUCCESSFULLY IN THEIR ENTIRETY. THE DOCTOR USED A NEW ENDOSCOPE TO CONFIRM THAT THEIR WAS NO INJURY TO THE PATIENT. NO HARM/INJURY EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527026 SEROSAFUSE IMPLANTABLE FASTENER ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE ENDOGASTRIC SOLUTIONS, INC. R2275 403070

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA