MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO; VALVE KIT

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	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The distributor reported that the button on the defendo single use valve kit is leaking during patient procedures.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the return of the device, the cause of the reported event cannot be determined.The defendo single use valve kit instructions for use states, "inspect packaging before use.Sterility is not guaranteed if package has been opened or damaged.Do not use if packaging or product is damaged or expired.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 record for the subject lot was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: DEFENDO
• Common Device Name: VALVE KIT
• 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: 24007450
• Report Number: 1651395-2026-00001
• Device Sequence Number: 4746314
• Product Code: FEQ
• UDI-Device Identifier: 00724995228941
• UDI-Public: (01)00724995228941(11)250806(17)280806(10)12688888
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K232329
• 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): 01/08/2026

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: DEFENDO FUJIFILM 700 SERIES
• Device Catalogue Number: 100333
• Device Lot Number: (10)12688888
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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