MAUDE Adverse Event Report: US Endoscopy DEFENDO; DEFENDO Olympus EUS Air Water Suction Valve Kit

Model Number	00711901
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported during a patient procedure their defendo olympus eus air water suction valve kit was "leaking" out of the distal tip of the scope, resulting in a procedure delay as the leak attributed to a loss in visualization.No report of injury.
Additional Manufacturer Narrative
Investigation in progress.A follow-up report will be submitted should additional information become available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: DEFENDO
• Common Device Name: DEFENDO Olympus EUS Air Water Suction Valve Kit
• Manufacturer (Section D): US Endoscopy; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US Endoscopy; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50147728
• Report Number: 1528319-2026-00091
• Device Sequence Number: 10602778
• Product Code: NWU
• UDI-Device Identifier: 00724995217402
• UDI-Public: (01)00724995217402
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/05/2026

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: 00711901
• Device Catalogue Number: 00711901
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 08/05/2026
• 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