MAUDE Adverse Event Report: Medivators Inc DEFENDO SINGLE USE VALVE KIT; Defendo Sigle Use Valve Kit

Model Number	100323
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while utilizing the biopsy valve to their defendo single use valve kit, the water ¿bubbled back up through the cap¿ and sprayed two employees in the face.The employees went to an eye washing station and flushed their eyes.No additional treatment was sought or administered.
Additional Manufacturer Narrative
The defendo air water suction and biopsy valve subject of the reported event is being returned for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.

• Brand Name: DEFENDO SINGLE USE VALVE KIT
• Common Device Name: Defendo Sigle 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 ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50237602
• Report Number: 1651395-2026-00016
• Device Sequence Number: 10297348
• Product Code: NWU
• UDI-Device Identifier: 00724995246839
• UDI-Public: (01)00724995246839(11)260526(17)290525(10)690969
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 08/13/2026

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: 100323
• Device Catalogue Number: 100323
• Device Lot Number: (10)690969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 05/26/2026
• 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