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

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Abdominal Pain (1685)

Event Date 07/12/2021

Event Type  Injury  

Event 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
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): M.I.TECH CO., LTD.; 174, habuk2-gil, jinwi-myeon; pyeongtaek, gyeonggi 17706 ; KS 17706
• MDR Report Key: 17412986
• MDR Text Key: 319935493
• Report Number: 2429304-2023-00248
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08806367088598
• UDI-Public: 08806367088598
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2021,07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention