MAUDE Adverse Event Report: MEDIVATORS INC ENDOGATOR AUXILIARY WATER JET CONNECTOR

Model Number	100241
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via vigilance report to ansm that they had leaks with their endogator auxiliary water jet connector.No report of injury or procedure delay.
Additional Manufacturer Narrative
The devices subject of the event were not returned to medivators for evaluation.Without return of the devices for evaluation, a root cause could not be determined.The device history record for the lot subject of the event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.The instructions for use state, "attach the endogator single use auxiliary water jet connector to the gi endoscope's auxiliary water port by engaging the threads and turning slowly until you feel resistance.Firmly attach to the endogator tube set's (intended for use with the 100241) backflow valve via the luer lock connection.Prior to the procedure, activate the footswitch and prime the tube set and gi endoscope with sterile water.If auxiliary water jet connector is leaking disconnect and replace with another adapter.Contact customer service about the leaking adapter for replacement instructions." medivators will continue to monitor for similar events to ensure the product performs as expected.No additional issues have been reported.

• Brand Name: ENDOGATOR AUXILIARY WATER JET CONNECTOR
• Common Device Name: WATER JET CONNECTOR
• 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: 19015346
• Report Number: 1651395-2024-00014
• Device Sequence Number: 4021074
• Product Code: OCX
• UDI-Device Identifier: 00677964058486
• UDI-Public: 00677964058486
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/01/2024

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: 100241
• Device Catalogue Number: 100241
• Device Lot Number: 575856
• 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: 07/31/2023
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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