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

Model Number	100242
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the lot subject of the reported event was reviewed and no abnormalities were noted.The instructions for use ((b)(4)) auxiliary water jet connector state: "open the sterile peel pack, remove the endogator single use auxiliary water jet connector, and attach it to the scope's auxiliary water port by inserting the nozzle end into the port and engaging the threads while turning clockwise steadily until you feel firm resistance.Connect the endogator tubing's (intended for use with the (b)(4)) backflow valve to the endogator single use auxiliary water jet connector via luer lock.Prior to the procedure, activate the pump footswitch and prime the endogator¿ tubing and gi endoscope with sterile water." there have been no other complaints associated with this lot.Without the return or inspection of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported that water leaked from the plugs while using their auxiliary water jet connector.No report of injury or procedure delay.

• 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: 18914258
• Report Number: 1651395-2024-00013
• Device Sequence Number: 6892994
• Product Code: OCX
• UDI-Device Identifier: 00677964058493
• UDI-Public: 00677964058493
• 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): 03/15/2024

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: 100242
• Device Catalogue Number: 100242
• Device Lot Number: 580003
• 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: 02/28/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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