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

• 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: 25770951
• Report Number: 1651395-2026-00010
• Device Sequence Number: 10472232
• Product Code: ODC
• UDI-Device Identifier: 00724995228903
• UDI-Public: (01)00724995228903(11)251111(17)281111(10)1308509
• 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: 100325
• Device Lot Number: (10)13085098
• 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: 11/11/2025
• 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