MAUDE Adverse Event Report: US ENDOSCOPY ULTRAMATRIX; ULTRAMATRIX EUS BALLOON OLYMPUS LINEAR

Model Number	USBOL
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch (b)(4) that the sides of their ultramatrix eus balloon olympus linear are sticking together and ripping when separated.No report of injury.
Additional Manufacturer Narrative
Investigation of the reported event is in process; a follow-up report will be submitted when additional information becomes available.

• Brand Name: ULTRAMATRIX
• Common Device Name: ULTRAMATRIX EUS BALLOON OLYMPUS LINEAR
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 23918681
• Report Number: 1528319-2025-00117
• Device Sequence Number: 9152360
• Product Code: ODG
• UDI-Device Identifier: 00724995180768
• UDI-Public: (01)00724995180768(11)250620(17)280620(10)OL63
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: USBOL
• Device Catalogue Number: USBOL
• Device Lot Number: (10)OL63
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 06/20/2025
• 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
• Patient Sex: Unknown