MAUDE Adverse Event Report: M.I. TECH CO., LTD. HANAROSTENT ESO TTS FC 20 DM 15CM 230

Model Number	ECBA-20-150-230
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Abdominal Pain (1685); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to an outside facility and underwent ct imaging due to abdominal pain, and it was revealed that a fragment of the stent had broken off and migrated into the small bowel, likely causing small bowel obstruction.Patient is scheduled for a double-balloon enterostomy to retrieve the broken stent.

• Brand Name: HANAROSTENT ESO TTS FC 20 DM 15CM 230
• Common Device Name: HANAROSTENT ESO TTS FC 20 DM 15CM 230
• Manufacturer (Section D): M.I. TECH CO., LTD.; 174 habuk 2-gil, jinwi-myeon; pyeongtaek, gyeonggi 17706 ; KS 17706
• MDR Report Key: 23531138
• Report Number: 2429304-2025-00292
• Device Sequence Number: 9020832
• Product Code: ESW
• UDI-Device Identifier: 08806367088598
• UDI-Public: 08806367088598
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/12/2025
• Report Date (Section F): 11/12/2025

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-20-150-230
• Device Lot Number: 54101229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2025
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• 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; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/12/2025