MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 16-17-18

Model Number	BD-400P-1880
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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 that during a therapeutic upper endoscopy procedure, the balloon of the subject device was not able to deflate and had to be cut in order to be removed.The procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.The device was not returned for evaluation and the customer's allegation could not be confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the performance of this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Common Device Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• 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: 22367344
• Report Number: 3011050570-2025-00665
• Device Sequence Number: 11916586
• Product Code: KNQ
• UDI-Device Identifier: 00821925033207
• UDI-Public: 00821925033207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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-400P-1880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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