MAUDE Adverse Event Report: MEDIVATORS, INC. ENDOGATOR HYBRID IRRIGATION TUBING

Model Number	100608S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Twelve unused tubing sets from lot number 514321 were returned for evaluation.Based on the evaluation of the tubing sets, a root cause could not be determined.The device history record of the lot subject of the reported event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.The endogator hybrid irrigation tubing instructions for use states, "place the printed section of the irrigation tubing, where the text "place in pump head." is printed, in the pump head and close.(note: ensure that the text "place in pump head." is centered, aligned and carefully pulled taut before closing the pump head.)" for endogator hybrid irrigation tubing models with connectors defining the tube segment placed within the pump head, the ifu states, "open the pump head, insert the pump tube of the irrigation tubing and close the pump head.(note: ensure that the pump tubing between the tubing connectors is centered, aligned, and carefully pulled taut before closing the pump head.)" the ifu further states, "connect the air/water connector of the endogator hybrid irrigation tubing to the air/water port of the gi endoscope with a firm pushing motion.Prime the tubing and the auxiliary water channel prior to use by activating the foot pedal; flush water through the entire gi endoscope.Turn on the air processor or co2.Prime the channel and test for air and water prior to insertion of gi endoscope into patient.If the water pressure is low, then ensure that the water bottle is tightly closed." no additional issues have been reported.
Event or Problem Description
The user facility reported that water leaks into the air tubing while using their endogator hybrid irrigation tubing.No report of injury or procedure delay.

• Brand Name: ENDOGATOR HYBRID IRRIGATION TUBING
• 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: 18319458
• Report Number: 1651395-2023-00030
• Device Sequence Number: 7437812
• Product Code: OCX
• UDI-Device Identifier: 00677964060861
• UDI-Public: 00677964060861
• 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): 12/13/2023

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: 100608S
• Device Catalogue Number: 100608S
• Device Lot Number: 514321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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