MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO; DEFENDO DISPOSABLE AIR/WATER 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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from their defendo disposable air/water valve.No report of injury or procedure delay.
Additional Manufacturer Narrative
The defendo disposable air/water valve subject of the reported event was not returned for evaluation.Without the return of the device a root cause cannot be determined.The instructions for use states, "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.Attach the single use suction valve to the endoscope's suction port.Push down, twisting slightly back and forth, until the valve engages.Prior to the procedure, turn on suction source and check suction by depressing the single use suction valve." steris counseled user facility personnel on the proper use and operation of the defendo disposable air/water valve, specifically the importance of properly engaging the valve to the endoscope.No additional issues have been reported.
Additional Manufacturer Narrative
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 DISPOSABLE AIR/WATER 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
• MDR Report Key: 22974407
• Report Number: 1651395-2025-00017
• Device Sequence Number: 18377228
• Product Code: ODC
• UDI-Device Identifier: 00677964060212
• UDI-Public: (01)00677964060212
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 09/04/2025

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: 100333
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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