MAUDE Adverse Event Report: M.I.TECH CO., LTD. HANAROSTENT?? ESOPHAGUS TTS (CCC)

Model Number	ECBA-20-100-230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted as an initial mdr by the manufacturer.The distributor also submitted a report reference no: (b)(4).Based on the description, this case involves the off-label use of an esophaseal stent in a duodenal procedure.Given this off-label use, we assume that the stent fracture occurred due to this inappropriate application of the product.Consequently, it is not possible to analyze the root cause base on the product's intended use.No further information is expected.The initial mdr submission was delayed because m.I.Tech was not aware that distributors had independently submitted mdrs, as several notifications were sent to an inactive email address and no internal process yet existed to routinely verify distributor-submitted reports.This gap has now been addressed through olympus staff retraining, initiation of a capa, and m.I.Tech's implementation of a regular review process to ensure timely identification of mdr-reportable events.
Event or Problem Description
Olympus sales representative (b)(4) reported the event on behalf of the treating physician, doctor (b)(6).According to the report, an esophageal stent was implanted in the patient's duodenum in (b)(6) 2024.The patient returned to the hospital in (b)(6) 2025, at which time a ct scan revealed that the implanted stent had fractured into two pieces, resulting in surgery to remedy the issue.The exact time point when the stent split into two pieces was not identified.
Additional Manufacturer Narrative
This follow-up report is intended to correct the coding terms that were either incorrectly entered or omitted in the previous report.This report is being submitted as an initial mdr by the manufacturer.The hospital also submitted a report (emdr-(b)(4), reference no: (b)(4).Based on the description, this case involves the off-label use of an esophaseal stent in a duodenal procedure.Given this off-label use, we assume that the stent fracture occurred due to this inappropriate application of the product.Consequently, it is not possible to analyze the root cause base on the product's intended use.
Event or Problem Description
It was reported that during a therapeutic stent removal for a duodenal stricture, the suspect device broke in half.The pieces were retrieved.The issue date was mentioned to be (b)(6) 2024.The device, esphageal stent, was placed in the duodenum of the patient.The patient returned to the hospital in (b)(6) 2025.A ct scan was completed and it was found that the implant had broken into two pieces, resulting in surgery to remedy the issue.No specific time was mentioned when the stent had split in 2 pieces.

• Brand Name: HANAROSTENT?? ESOPHAGUS TTS (CCC)
• Common Device Name: HANAROSTENT?? ESOPHAGUS TTS (CCC)
• Manufacturer (Section D): M.I.TECH CO., LTD.; 174 habuk 2-gil, jinwi-myeon; pyeongtaek, gyeonggi, 17706 ; KS 17706
• Manufacturer Contact: taejun kwon ; 174 habuk 2-gil, jinwi-myeon; pyeongtaek, gyeonggi, 17706 ; KS 17706
• MDR Report Key: 23775589
• Report Number: 3008146331-2025-00005
• Device Sequence Number: 10131354
• Product Code: ESW
• UDI-Device Identifier: 08806367088529
• UDI-Public: 08806367088529
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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-20-100-230
• Device Lot Number: 24101248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown