MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 13.5-14.5-15.5; DILATOR, ESOPHAGEAL

Model Number	BD-400P-1580
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported subject device, was expanded until it reached about 14 mm, at which point the expansion was stopped and an attempt was made to pull the balloon out of the endoscope's biopsy channel, but the balloon could not be pulled out.The issue occurred during a therapeutic esophageal dilation procedure that was completed with the same device with delay.There was no report of patient harm.
Additional Manufacturer Narrative
E1: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
Updated field(s): d8, d9, h3, h6, h11.This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection.Based on the results of the investigation, the complaint was confirmed, and the cause was determined due to component failure of the balloon.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 customer.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to a previously submitted report.Corrected field: h6 medical device problem code 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 customer.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide final investigation results.The device was returned to olympus for product analysis.Visual examination of the device identified wrinkles and indentations in the balloon that support the reported event details that the balloon could not be pulled out through the biopsy channel.While it cannot be determined at what point these wrinkles or deformations occurred, they can likely be attributed to the balloon being inflated and deflated during use and the attempts to remove it from the scope using force, which would have resulted in the deformation observed.The balloon was functionally tested and confirmed to inflate normally.The root cause for being unable to withdraw the balloon from the endoscope's biopsy channel could not be determined.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 (FW) 13.5-14.5-15.5
• Common Device Name: DILATOR, ESOPHAGEAL
• 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: 22901769
• Report Number: 3011050570-2025-00961
• Device Sequence Number: 8814240
• Product Code: KNQ
• UDI-Device Identifier: 00821925033191
• UDI-Public: 00821925033191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT-KNQ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/05/2025

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-400P-1580
• Device Lot Number: 424171
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/27/2025; 12/04/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/06/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown