MAUDE Adverse Event Report: US Endoscopy DEFENDO; Single Use Valve Kit

Model Number	00711901
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure with the use of a defendo single use valve kit, the balloon started deflating without the user depressing the suction valve subsequently causing water to leak into the patient.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The air/water and one suction button were returned to steris for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.

• Brand Name: DEFENDO
• Common Device Name: Single Use 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: 50000079
• Report Number: 1528319-2026-00088
• Device Sequence Number: 10659343
• Product Code: NWU
• UDI-Device Identifier: 00724995217402
• UDI-Public: (01)00724995217402(11)260508(17)290508(10)13872266
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/22/2026

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: 00711901
• Device Catalogue Number: 00711901
• Device Lot Number: (10)13872266
• 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: 06/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 05/08/2026
• 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