MAUDE Adverse Event Report: GYRUS ACMI, LLC OLYMPUS EZDILATE; DILATOR, ESOPHAGEAL

Model Number	BD-400P-1380
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The esophageal balloon did not completely deflate with equipment used for this, needed to manually deflate with a syringe.Dilator would not lock, and balloon would not stay dilated to mm setting, you had to continuously add to balloon.

• Brand Name: OLYMPUS EZDILATE
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, LLC; 800 west park drive; westborough MA 01581
• MDR Report Key: 20225399
• Report Number: 20225399
• Device Sequence Number: 7240608
• Product Code: KNQ
• UDI-Device Identifier: 00821925033184
• UDI-Public: (01)00821925033184(17)260806(10)395313
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024
• Report Date (Section F): 05/24/2024

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-1380
• Device Lot Number: 395313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Date Report Sent to FDA: 05/24/2024