MAUDE Adverse Event Report: MEDIVATORS, INC. ENDOGATOR BACKFLOW VALVE

Model Number	100126
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following warnings related to backflow are from the endogator tubing and accessories instructions for use, "ensure that tubing and irrigation flow is functioning properly.If there is any reason to believe that the endogator system was contaminated, immediately discard the entire endogator irrigation tubing, accessories and water bottle.Replace with new endogator irrigation tubing, accessories and unopened sterile water bottle." in a review of complaint over the last 2 years, this is the only reported occurrence of this event.Medivators will continue to monitor for similar events and to ensure the product performs as intended.
Event or Problem Description
The user facility reported that post-procedure, during the pre-cleaning process, procedural matter was observed to be flowing past the medivators endogator backflow valve through the irrigation tubing.The reported event did not occur during a patient procedure and a patient was not present at the time of the event.Additionally, no harm or adverse event to user facility personnel was reported as a result of the event.

• Brand Name: ENDOGATOR BACKFLOW VALVE
• Common Device Name: ENDOGATOR BACKFLOW VALVE
• 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 ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 12677615
• Report Number: 1651395-2021-00003
• Device Sequence Number: 14288518
• Product Code: FEQ
• UDI-Device Identifier: 00677964058455
• UDI-Public: 00677964058455
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K092429
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: Lay User/Patient
• Device Expiration Date: 06/01/2024
• Device Model Number: 100126
• Device Lot Number: 509488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown