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

Model Number	DEFENDO FUJIFILM 700 SERIES
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure they were having issues with the suction button to their defendo single use valve kit resulting in a loss of specimens.Report of procedure delay.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the returned device, a root cause cannot be determined.The instructions for use for the defendo single use valves with the fujifilm 700 series gi endoscopes states "always wear gloves and other appropriate personal protective equipment while handling, such as gown and face mask.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." the device history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A three-year complaint review confirmed the reported event to be isolated.No additional issues have been reported.

• Brand Name: DEFENDO
• Common Device Name: DEFENDO SINGLE USE 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
• MDR Report Key: 21778530
• Report Number: 1651395-2025-00005
• Device Sequence Number: 8000661
• Product Code: FDF
• UDI-Device Identifier: 00724995228903
• UDI-Public: (01)00724995228903(11)240922(17)270922(10)11052018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/04/2025

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: 100325
• Device Lot Number: (10)11052018
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2024
• 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