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

Model Number	100609
Medical Device Problem Codes	Leak/Splash (1354); Device Handling Problem (3265)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure which included use of the endogator hybrid tubing, sterile water leaked from the endoscope obscuring the physician's field of vision.No report of injury or procedure delay.
Additional Manufacturer Narrative
Steris requested the endogator hybrid irrigation tubing subject of the reported event for evaluation however, the subject tubing was not available for evaluation.Without the return of the endogator hybrid irrigation tubing a root cause can not be determined.The device review history (dhr) for the subject lot was reviewed, and no abnormalities were found.There are no other complaints associated with the subject lot.Directions in the instructions for use include "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.
Additional Manufacturer Narrative
The endogator hybrid irrigation tubing subject of the reported event was returned for evaluation and no issues were noted with the function or operation of the unit.The device history record (dhr) for the subject lot was reviewed, and no abnormalities were found.Further investigation into the root cause of the reported event was conducted.Based on the description of the reported event and the evaluation results of the returned device, it is likely that the pump tube was incorrectly placed within the pump head by user facility personnel.Should the pump tube be incorrectly placed, this can allow water to pass beyond the pump head and dispense water at the distal end of the scope resulting in the reported event.Users are expected to follow the instructions outlined for placing the pump tube within the endogator hybrid irrigation tubing instructions for use (ifu).For endogator hybrid irrigation tubing models with an imprint on the tube segment placed within the pump head, the ifu 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 tub 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." directions in the ifu also include "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." a steris product specialist counseled user facility personnel on the proper use and operation of the endo stratus co2 insufflator and endogator hybrid tubing.No additional issues have been reported.

• Brand Name: ENDOGATOR HYBRID IRRIGATION TUBING
• Common Device Name: 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: 17316600
• Report Number: 1651395-2023-00016
• Device Sequence Number: 17161298
• Product Code: OCX
• UDI-Device Identifier: 00677964052354
• UDI-Public: 00677964052354
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/13/2023

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: 100609
• Device Lot Number: 576408
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 06/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/24/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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