MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO AIR/WATER/SUCTION AND BIOPSY VALVE; DEFENDO BIOPSY VALVE

Model Number	100305
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, their defendo biopsy valve was leaking resulting in a short procedure delay.The procedure was completed successfully using a different device.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was discarded by user facility personnel.Without the return and evaluation of the device an exact cause cannot be determined.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: DEFENDO AIR/WATER/SUCTION AND BIOPSY VALVE
• Common Device Name: DEFENDO BIOPSY 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: 23030679
• Report Number: 1651395-2025-00019
• Device Sequence Number: 13065631
• Product Code: ODC
• UDI-Device Identifier: 00677964060250
• UDI-Public: (01)00677964060250(11)250422(17)280403(10)656957
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K102581
• 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): 09/11/2025

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: 100305
• Device Catalogue Number: 100305
• Device Lot Number: (10)656957
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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