MAUDE Adverse Event Report: Medivators Inc ENDOGATOR; Auxiliary Water Jet Connector

Model Number	100241
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure the endogator auxiliary water jet connector ¿cracked¿ subsequently causing water to leak onto the floor.Another device was utilized and the procedure was completed successfully following a short delay.No report of injury.
Additional Manufacturer Narrative
The endogator auxiliary water jet connector subject of the event was disposed of by user facility personnel.As the device is not available for return or evaluation, the cause of the reported event could not be determined.The device history record was reviewed for the subject lot and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: ENDOGATOR
• Common Device Name: Auxiliary Water Jet Connector
• 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: 50479600
• Report Number: 1651395-2026-00017
• Device Sequence Number: 15975978
• Product Code: FEQ
• UDI-Device Identifier: 00677964058486
• UDI-Public: (01)00677964058486(17)280922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 100241
• Device Catalogue Number: 100241
• Device Lot Number: (10)671699
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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