MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. Single Use Biliary Balloon Dilator; Stents, Drains And Dilators For The Biliary Ducts

Model Number	BD-210N-0440
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to a previously submitted report and investigation results.Corrected fields: d9, g1, h3, h4.The device was returned to olympus for inspection, and the reported failure was confirmed.A definite root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: there was a crack on the balloon lumen hub.The balloon could not inflate.A device history record review was completed, and no issues were identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: Single Use Biliary Balloon Dilator
• Common Device Name: Stents, Drains And Dilators For The Biliary Ducts
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50274152
• Report Number: 9614641-2026-00837
• Device Sequence Number: 10286353
• Product Code: FGE
• UDI-Device Identifier: 04953170399992
• UDI-Public: 04953170399992
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: BD-210N-0440
• Device Lot Number: 58K 20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown