MAUDE Adverse Event Report: MEDIVATORS, INC. ENDOGATOR 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	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their endogator tubing is being lacerated in the pumps during procedures and causing water to leak onto the floor.No report of injury.
Additional Manufacturer Narrative
One of the damaged devices was returned to medivators for evaluation and confirmed the tubing was cracked resulting in the reported event.The investigation into the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The endogator tubing evaluation determined that the cause of tubes lacerating in pump was likely the result of the user facility using new pump heads.The user facility had replaced old pump heads with new pump heads (with new rollers).When the pump was turned up to max flow, the water pressure built up in front of the rollers faster than it can be expelled through the tubing causing the roller to damage the tubing.The user facility was counseled to turn down the flow rate during the initial use of the new roller heads to prevent this issue.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." no additional issues have been reported.

• Brand Name: ENDOGATOR 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: 15514903
• Report Number: 1651395-2022-00018
• Device Sequence Number: 5170893
• 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): 09/29/2022

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: 100130
• Device Catalogue Number: 100130
• Device Lot Number: 537116
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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