MAUDE Adverse Event Report: Medivators Inc ENDOGATOR; Endogator Tubing

Model Number	200230
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from their endogator tubing during a patient procedure.No report of injury.
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.

• Brand Name: ENDOGATOR
• Common Device Name: Endogator Tubing
• 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: 50718491
• Report Number: 1651395-2026-00019
• Device Sequence Number: 10641147
• Product Code: OCX
• UDI-Device Identifier: 00677964058516
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K220395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 200230
• Device Catalogue Number: 200230
• Device Lot Number: (10)677579
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/10/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown