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

Model Number	100322
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification: the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that the biopsy valve to their defendo single use valve kit leaked and sprayed water onto user facility personnel.No report of injury.
Additional Manufacturer Narrative
The devices subject of the event were not available for evaluation.Without the return and evaluation of the devices, the cause of the reported event cannot be determined.The user facility was unable to provide the lot number for the defendo disposable biopsy valve; therefore, a review of the device history record could not be performed.Steris will continue to monitor for similar events to ensure the product continues to perform as expected.No additional issues have been reported.

• Brand Name: DEFENDO SINGLE USE VALVE KIT
• 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 ; 4402597401
• MDR Report Key: 22977110
• Report Number: 1651395-2025-00018
• Device Sequence Number: 13104120
• Product Code: NWU
• UDI-Device Identifier: 00677964092992
• UDI-Public: (01)00677964092992
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/05/2025

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: 100322
• Device Catalogue Number: 100322
• 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: 09/05/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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