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

Model Number	ECBA-20-150-230
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus representative reported to olympus, on behalf of the customer, the esophageal hanarostent was used off label and placed in the patient's upper duodenum.It was in the patient for a period of time and the patient complained of abdominal pain and went to the emergency room.It was found through a scan that the device became dislodged and broke in half.The patient was taken for surgery to remove the device.There were no reports of patient harm associated with this event.

• Brand Name: HANAROSTENT ESO TTS FC 20 DM 15CM 230
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): M.I.TECH CO., LTD.; 174, habuk2-gil, jinwi-myeon; pyeongtaek, gyeonggi 17706 ; KS 17706
• MDR Report Key: 17412986
• Report Number: 2429304-2023-00248
• Device Sequence Number: 13005699
• Product Code: ESW
• UDI-Device Identifier: 08806367088598
• UDI-Public: 08806367088598
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2023
• Report Date (Section F): 07/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ECBA-20-150-230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown