MAUDE Adverse Event Report: OLYMPUS AMERICA, INC HANAROSTENT ESO TTS FC 20 DM 15CM 230; POLYMER-METAL OESOPHAGEAL STENT

Model Number	ECBA-20-150-230
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an esophagogastroduodenoscopy (egd) and removal of an esophageal hanarostent (that had been placed a month prior at a different location), the stent broke apart during removal.The physician was not able to remove all of the stent pieces.The physician was not concerned because the customer was scheduled for another unspecified surgery next week.No additional consequences to the patient were reported.

• Brand Name: HANAROSTENT ESO TTS FC 20 DM 15CM 230
• Common Device Name: POLYMER-METAL OESOPHAGEAL STENT
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 15997593
• Report Number: 2429304-2022-00174
• Device Sequence Number: 17812163
• Product Code: KAC
• UDI-Device Identifier: 08806367088598
• UDI-Public: 08806367088598
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2022
• Report Date (Section F): 11/17/2022

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• 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: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 80 KG