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	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during patient procedures, the endogator irrigation tubing that attaches to their endo stratus irrigation pumps was cracking allowing water to leak onto the floor and subsequently causing procedure delays.User facility personnel replaced the tubing, cleaned up the water, and the procedures were completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris product specialist spoke with user facility personnel who stated that the endo stratus irrigation pumps were continuously being utilized at 100% flow rate.The endo stratus irrigation pump instructions for use include the following instructions for proper operation of the pump including flow rates.The ifu states, "the flow control should always be set at the lowest setting at the start of the procedure and be increased incrementally to a level commensurate with the clinical condition of the patient and the degree of irrigation required.Excessive water pressure may result in damage or injury to patient including perforation of patient anatomy." the ifu further states, "always watch for abnormal flow rates and adjust the flow rate as necessary.If an unusual flow rate remains after adjustments have been made, then stop the procedure and investigate.Only qualified medical personnel in an acceptable medical facility should operate the endo stratus irrigation pump.The instructions for use described in this manual must be followed.Otherwise, compromised safety, malfunction, injury to the operator and/or patient, or costly damage to the unit and other equipment may occur." the endogator tubing subject of the reported events was not returned to medivators for evaluation.Without the returned devices, the root cause cannot be determined.The steris product specialist counseled user facility personnel on the proper use and operation of the endo stratus irrigation pump, specifically on how to properly adjust flow rates.No additional issues have been reported.
Additional Manufacturer Narrative
The endogator tubing subject of the reported events was not returned to medivators for evaluation.Without the returned devices, the root cause cannot be determined.However, based on the description of the event, the root cause may have been attributed to constant use of the maximum (100%) flow rate by user facility personnel.A medivators product specialist counseled user facility personnel on the proper use and operation of the endo stratus irrigation pump, specifically on how to properly adjust flow rates.No additional issues have been reported.

• Brand Name: ENDOGATOR 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: 15839719
• Report Number: 1651395-2022-00031
• Device Sequence Number: 17891536
• Product Code: OCX
• UDI-Device Identifier: 00677964058462
• UDI-Public: 00677964058462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 11/21/2022

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: 100130
• Device Catalogue Number: 100130
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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