MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO; VALVE

Model Number	DEFENDO FUJIFILM 700 SERIES
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices subject of the reported event ere not returned for evaluation.Without the returned device, a cause cannot be determined.The instructions for use for the defendo single use valves states "always wear gloves and other appropriate personal protective equipment while handling, such as gown and face mask.Attach the single use biopsy valve onto the endoscope's biopsy port.Push down until the biopsy valve engages.Always make sure the lid of the single use biopsy valve is closed.Attach the single use air/water valve to the endoscope's air/water port.Push down, twisting slightly back and forth, until the valve engages.Prior to the procedure, depress single use air/water valve to prime air/water channel." the device history records were reviewed and confirmed the lots were manufactured to specifications; no abnormalities were noted.A steris account manager performed in-service training on the proper use and operation of the defendo valves.No additional issues have been reported.We will continue to monitor to ensure the product continues to perform as expected.
Event or Problem Description
The distributor reported from a user facility that during a patient procedure the air/water valve and biopsy valve to their defendo single use valve kit leaked and sprayed water onto user facility personnel.The procedure was completed successfully.No report of injury or procedure delay.

• Brand Name: DEFENDO
• Common Device Name: VALVE
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4402597401
• MDR Report Key: 25770988
• Report Number: 1651395-2026-00011
• Device Sequence Number: 18768800
• Product Code: ODC
• UDI-Device Identifier: 00724995228958
• UDI-Public: (01)00724995228958(11)250821(17)280821(10)12730998
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K232329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: DEFENDO FUJIFILM 700 SERIES
• Device Catalogue Number: 100355
• Device Lot Number: (10)12730998, (10)13052300
• Was Device Available for Evaluation?: No
• 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: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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