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

Model Number	ECBA-20-100-180
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep.(b)(6) called, and reported an issue, where the inner tube of the delivery system became lodged in a gif-1tq160 when the outer sheath was removed post stent deployment.

• Brand Name: HANAROSTENT ESOPHAGUS TTS (CCC)
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): M.I.TECH CO.,LTD.; pyeongtaek-si, gyoenggi-do ; KS
• MDR Report Key: 12305651
• Report Number: 3008146331-2021-00002
• Device Sequence Number: 5156719
• Product Code: ESW
• UDI-Device Identifier: 08806367088482
• UDI-Public: 08806367088482
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: ECBA-20-100-180
• Device Catalogue Number: ECBA-20-100-180
• Device Lot Number: 20100290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1