MAUDE Adverse Event Report: M.I.TECH CO., LTD. HANAROSTENT ESO TTS FC 20 DM 12CM 180; PROSTHESIS, ESOPHAGEAL

Model Number ECBA-20-120-180

Device Problem Migration (4003)

Patient Problem Perforation (2001)

Event Date 06/03/2021

Event Type  Injury  

Event Description

An olympus representative reported to olympus, on behalf of the customer, the hanarostent was implanted in the esophagus of the patient, migrated into the stomach and caused a pneumoperitoneum.Dr.(b)(6) had also found a perforation in the stomach and he closed it off with two clips.There were no reports of patient harm associated with this event.

• Brand Name: HANAROSTENT ESO TTS FC 20 DM 12CM 180
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): M.I.TECH CO., LTD.; 174, habuk 2gil, jinwimyeon; pyeongtaek, gyeonggi 17706 ; KS 17706
• MDR Report Key: 17413676
• MDR Text Key: 319939717
• Report Number: 2429304-2023-00249
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08806367088529
• UDI-Public: 08806367088529
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2021,07/28/2023

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-20-120-180
• Device Lot Number: 20060968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention