BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT ESOPHAGUS TTS(CCC)

    MDR report key: 11816810 · Received May 13, 2021

    Report

    Report Number
    11816810
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 11, 2021
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILE PROCESSING DEPARTMENT (SPD) STAFF DISCOVERED LODGED INSIDE OF SCOPE 117 OUR THERAPEUTIC UPPER SCOPE. UPON FURTHER REVIEW NOTED THAT ITEM LODGED INSIDE OF SCOPE WAS PART OF OLYMPUS STENT THAT HAD BEEN USED FOR EARLIER CASE. ITEM APPEARS TO BE PART OF THE STENT TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718254 HANAROSTENT ESOPHAGUS TTS(CCC) PROSTHESIS, ESOPHAGEAL ESW M.I.TECH CO., LTD. ECBA-20-100-180 20100290

    Patients

    Seq Age Sex Outcome Treatment
    1