MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE - FIXED WIRE ESOPHAGEAL 3-STAGE BALLOON DILATATION CATHETER; DILATOR, ESOPHAGEAL

Model Number	BD-400P-2080
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Inflation balloon would not deflate enough to be removed from the scope.Used the pump to deflate- it went down but not enough to be removed from the scope.Disconnected the pump and connected a syringe and tried to remove any water.Tried to remove the balloon again and it would not budge.Had to remove scope and cutters to cut in 1/2 to get the equipment out of the scope.

• Brand Name: EZDILATE - FIXED WIRE ESOPHAGEAL 3-STAGE BALLOON DILATATION CATHETER
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 18525982
• Report Number: 18525982
• Device Sequence Number: 7858844
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: (01)00821925033214(17)260323(10)381560
• 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): 09/07/2023
• Report Date (Section F): 09/07/2023

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: Other
• Device Model Number: BD-400P-2080
• Device Lot Number: 381560
• 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: 01/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2024
• 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 Sex: Male
• Date Report Sent to FDA: 09/07/2023