MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 11-12-13

Model Number	BD-410X-1355
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ezdilate balloon dilator would not hold sterile water and stay inflated.The issue occurred during a therapeutic esophagogastroduodenoscopy procedure and was completed using an olympus back-up device.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation/inspection.Based on the results of the investigation, the balloon device would not hold sterile water and stay inflated could not be identified.A definitive root cause could not be established.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 11-12-13
• Common Device Name: EZDILATE BALLOON DILATOR (WG) 11-12-13
• 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: 22637339
• Report Number: 3011050570-2025-00796
• Device Sequence Number: 7990394
• Product Code: FGE
• UDI-Device Identifier: 00821925033245
• UDI-Public: 00821925033245
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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-1355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Race: White