MAUDE Adverse Event Report: US ENDOSCOPY ULTRAMATRIX; ULTRASOUND ENDOSCOPE BALLOON

Model Number	USBOR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when the ultramatrix eus balloons were placed at the end of their endoscope, only half of the image was displayed on their display monitor.Facility personnel utilized another balloon to complete the procedure which resulted in a short procedure delay.No report of injury.
Additional Manufacturer Narrative
The ultramatrix eus balloon subject of the reported event is being returned to the supplierfor evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.

• Brand Name: ULTRAMATRIX
• Common Device Name: ULTRASOUND ENDOSCOPE BALLOON
• 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: 24471361
• Report Number: 1528319-2026-00019
• Device Sequence Number: 21409702
• Product Code: ODG
• UDI-Device Identifier: 00724995180775
• UDI-Public: (01)00724995180775(11)250415(17)280415(10)OR53
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: USBOR
• Device Catalogue Number: USBOR
• Device Lot Number: (10)OR53, (10)OR54
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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