MAUDE Adverse Event Report: MEDIVATORS INC. ENDOGATOR; IRRIGATION TUBING

Model Number	100130
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their endogator irrigation tubing was leaking water at the connection to the co2 pump onto the floor.User facility personnel changed the tubing resulting in a short procedure delay.No report of injury.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.Without the returned device, a root cause cannot be determined.The lot history record for the device subject of the event was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.There have been no similar complaints for this lot.No additional issues have been reported.

• Brand Name: ENDOGATOR
• Common Device Name: IRRIGATION TUBING
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC.; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 21071855
• Report Number: 1651395-2025-00001
• Device Sequence Number: 8398832
• Product Code: OCX
• UDI-Device Identifier: 00677964058462
• UDI-Public: (01)00677964058462(17)260809(10)595972
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K220395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 08/09/2026
• Device Model Number: 100130
• Device Catalogue Number: 100130
• Device Lot Number: (10)595972
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown