MAUDE Adverse Event Report: M.I. TECH CO., LTD. HANAROSTENT ESO TTS FC 20 DM 8CM 230

Model Number	ECBA-20-080-230
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an unspecified therapeutic procedure, the stent broke apart inside the patient and was successfully removed through an unspecified medical intervention.There were no reports of further patient harm.
Event or Problem Description
Additional information received from the customer indicated that the stent was placed in the esophagus and did not fall into the body.The stent was retrieved with forceps.The unspecified therapeutic procedure was prolonged less than 30 minutes with no reports of patient harm and no change in treatment course.This event was initially reported as a serious injury; however, due to additional information received from the customer, it was determined the device did not contribute to a serious injury as there was no harm to the patient.Updated fields: b5, f7 and f10 health effect - impact code to f26.

• Brand Name: HANAROSTENT ESO TTS FC 20 DM 8CM 230
• Common Device Name: HANAROSTENT ESO TTS FC 20 DM 8CM 230
• Manufacturer (Section D): M.I. TECH CO., LTD.; 174 habuk 2-gil, jinwi-myeon; pyeongtaek, gyeonggi 17706 ; KS 17706
• MDR Report Key: 24512007
• Report Number: 2429304-2026-00029
• Device Sequence Number: 10486127
• Product Code: ESW
• UDI-Device Identifier: 08806367088451
• UDI-Public: 08806367088451
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026
• Report Date (Section F): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ECBA-20-080-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 06/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/04/2026