MAUDE Adverse Event Report: Gyrus ACMI, Inc. EZDILATE BALLOON DILATOR (WG) 16-17-18; Stents, Drains And Dilators For The Biliary Ducts

Model Number	BD-410X-1855
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
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 not returned to olympus for inspection, and the reported failure was confirmed.The probable cause was traced to component failure.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: EZDILATE BALLOON DILATOR (WG) 16-17-18
• Common Device Name: Stents, Drains And Dilators For The Biliary Ducts
• Manufacturer (Section D): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50168846
• Report Number: 3011050570-2026-00795
• Device Sequence Number: 5305658
• Product Code: FGE
• UDI-Device Identifier: 00821925033269
• UDI-Public: 00821925033269
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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-410X-1855
• Device Lot Number: 516345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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