MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 18-19-20

Model Number	BD-410X-2055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the subject device wire broke during a balloon removal.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated field(s): d4, d8, d9, g1, h2, h3, h5, h6, h8, h11.The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the results of the investigation, olympus confirmed the device wire was broken; however, the most probable cause of the complaint is cause not established likely due to stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the subject device wire broke during a balloon removal.There were no reports of patient harm.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 18-19-20
• Common Device Name: EZDILATE BALLOON DILATOR (WG) 18-19-20
• 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 ; 5082077661
• MDR Report Key: 21223048
• Report Number: 3011050570-2025-00063
• Device Sequence Number: 8639882
• Product Code: FGE
• UDI-Device Identifier: 00821925033276
• UDI-Public: 00821925033276
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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-2055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown