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

Model Number	100312
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is in progress.Steris has requested the device subject of the reported event be returned for evaluation.A follow-up report will be submitted should more information become available.
Event or Problem Description
The user facility reported that the air water valve for the defendo single use valve kit stopped working during a patient procedure resulting in the procedure being postponed.No report of injury.

• 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
• MDR Report Key: 22751098
• Report Number: 1651395-2025-00015
• Device Sequence Number: 15632294
• Product Code: ODC
• UDI-Device Identifier: 00677964094682
• UDI-Public: (01)00677964094682(11)230915(17)260823(10)597512
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K232067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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 Expiration Date: 09/15/2023
• Device Model Number: 100312
• Device Catalogue Number: 100312
• Device Lot Number: (10)597512
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 09/15/2023
• 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