MAUDE Adverse Event Report: Gyrus ACMI, Inc. EZDILATE BALLOON DILATOR (FW) 18-19-20; Dilator, Esophageal

Model Number	BD-400P-2080
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic egd (esophagogastroduodenoscopy) the balloon only partially deflated.Attempts to remove the balloon both through the scope and simultaneously with the scope was met with resistance.There was an injury to the esophagus with mid to moderate amount of bleeding which required clipping.After the scope was removed from the patient, the balloon was removed without being cut and it was noted that the balloon was bunched at the end.The reported event resulted in a procedural prolongation of less than 30 minutes.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• 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 ; +1(508)207-7661
• MDR Report Key: 50083150
• Report Number: 3011050570-2026-00770
• Device Sequence Number: 21512659
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: 00821925033214
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 522762
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown