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

Model Number	BD-400P-2080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported upon the completion of an esophagogastroduodenoscopy (esg), the user was unable to deflate the subject device.The user had to cut the balloon to remove it.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: h2, h6, h11.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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer that was inadvertently left out of the initial submission.Updated fields: d4 - lot #, d8, h2, h4 - device mfg date, and h6.Corrected fields: b1, b2, b5, h1, and h6.Olympus will continue to monitor field performance for this device.
Event or Problem Description
After the dilation was completed during a diagnostic esophagogastroduodenoscopy, the clinical team was unable to cut the balloon.The staff attempted to remove the balloon by cutting it, but in the process, a piece of plastic detached from the device and remained inside the patient.To safely retrieve the detached fragment without compromising the patient's airway, the patient required endotracheal intubation.The fragment was successfully retrieved and the procedure was completed.Following the event, the patient experienced an increase in pain, rated 5-6/10.Pain persisted into the following day, and the patient was sent for an x-ray to rule out retained material or other complications.The x-ray results were normal.The patient remained otherwise stable throughout the entire event.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Common Device Name: EZDILATE BALLOON DILATOR (FW) 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: 22493144
• Report Number: 3011050570-2025-00716
• Device Sequence Number: 14477302
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: 00821925033214
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Nurse
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BD-400P-2080
• Device Lot Number: 467942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 06/18/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H190 VIDEO GASTROSCOPE, SERIAL NUMBER (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 62 KG