BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT ESO TTS FC 20 DM 15CM 230

    MDR report key: 15997593 · Received December 16, 2022

    Report

    Report Number
    2429304-2022-00174
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 16, 2022
    Manufacturer
    OLYMPUS AMERICA, INC
    Product Code
    KAC
    UDI-DI
    08806367088598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND REMOVAL OF AN ESOPHAGEAL HANAROSTENT (THAT HAD BEEN PLACED A MONTH PRIOR AT A DIFFERENT LOCATION), THE STENT BROKE APART DURING REMOVAL. THE PHYSICIAN WAS NOT ABLE TO REMOVE ALL OF THE STENT PIECES. THE PHYSICIAN WAS NOT CONCERNED BECAUSE THE CUSTOMER WAS SCHEDULED FOR ANOTHER UNSPECIFIED SURGERY NEXT WEEK. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747530 HANAROSTENT ESO TTS FC 20 DM 15CM 230 POLYMER-METAL OESOPHAGEAL STENT KAC OLYMPUS AMERICA, INC ECBA-20-150-230 UNKNOWN 08806367088598

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other| R