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

Model Number	ECBA-20-100-180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
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 stent issue (stent fracture) of an esophaseal stent.We are currently confirming through the distributor whether the product can be retrieved.If the product becomes available, we will perform a product analysis and prepare the report by identifying the most probable root cause.If the product cannot be retrieved, the report will be prepared based on theoretical analysis and a review of the device history record (dhr).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
The customer (b)(6) reported to olympus representative (b)(4) that the ecba-20-100-180 hanaro stent was placed in the patient on (b)(6) and fractured and broke apart in the patient.The doctor retrieved both pieces from the patient.
Event or Problem Description
The customer (b)(6) reported to olympus representative (b)(6) that the ecba-20-100-180 hanaro stent was placed in the patient on march 1 and fractured and broke apart in the patient.The doctor retrieved both pieces from the patient.
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 distributor also submitted a report (reference no: (b)(4)).Based on the description, this case involves the stent issue (stent fracture) of an esophaseal stent.We are currently confirming through the distributor whether the product can be retrieved.If the product becomes available, we will perform a product analysis and prepare the report by identifying the most probable root cause.If the product cannot be retrieved, the report will be prepared based on theoretical analysis and a review of the device history record (dhr).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.

• 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: 23775586
• Report Number: 3008146331-2025-00006
• Device Sequence Number: 18664898
• Product Code: ESW
• UDI-Device Identifier: 08806367088529
• UDI-Public: 08806367088529
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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-20-100-180
• Device Lot Number: UNKNOWN
• 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