MAUDE Adverse Event Report: Medivators Inc DEFENDO Air/Water/Suction and Biopsy Valve; DEFENDO Air Water Suction and Biopsy Valve

Model Number	100305
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction

• Brand Name: DEFENDO Air/Water/Suction and Biopsy Valve
• Common Device Name: DEFENDO Air Water Suction and 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 ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50154814
• Report Number: 1651395-2026-00014
• Device Sequence Number: 13412390
• Product Code: ODC
• UDI-Device Identifier: 00724995246723
• UDI-Public: (01)00724995246723(17)290525(10)691100
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102581
• 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): 08/06/2026

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: 100305
• Device Catalogue Number: 100305
• Device Lot Number: (10)691100,(10)687550
• 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: 07/09/2026
• Initial Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 04/13/2026
• 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