MAUDE Adverse Event Report: ATRION MEDICAL PRODUCTS, INC. OLYMPUS ENDOTHERAPY¿ INFLATION DEVICE FOR ENDOSCOPIC BALLOON DILATION; DILATOR, URETHRAL

Model Number	QL® 6015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was doing a balloon dilation of fibrotic stricture about 10 cm into the terminal ileum that the colonoscope could not pass.A colonic balloon was introduced through scope's accessory channel and used to dilate the stricture up to 11 mm.During the dilation the balloon failed and water that was used to inflate leaked from balloon.A new balloon was obtained and the dilation was performed with no issues.

• Brand Name: OLYMPUS ENDOTHERAPY¿ INFLATION DEVICE FOR ENDOSCOPIC BALLOON DILATION
• Common Device Name: DILATOR, URETHRAL
• Manufacturer (Section D): ATRION MEDICAL PRODUCTS, INC.; 1426 curt francis rd.; arab AL 35016
• MDR Report Key: 8300929
• Report Number: 8300929
• Device Sequence Number: 154443
• Product Code: KOE
• UDI-Device Identifier: 00856877002537
• UDI-Public: (01)00856877002537(17)210531(10)96379048
• 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): 01/23/2019
• Report Date (Section F): 01/23/2019

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: QL® 6015
• Device Catalogue Number: MAJ-1740
• Device Lot Number: 96379048
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 106
• Date Report Sent to FDA: 01/23/2019