MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO DISPOSABLE SUCTION VALVE

Model Number	100315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility did not provide additional details regarding the reported event or procedure delays.The valves subject of the reported event are not being returned to medivators for evaluation.As the valves are not being returned, we are unable to determine the root cause of the reported event.Medivators tested multiple lots of current inventory and no issues were noted.The dhr for the lot subject of the reported event was reviewed and no issues were noted.Medivators performed in-service training on the proper use and operation of the defendo-pentax valve kit.
Event or Problem Description
The user facility reported during patient procedures the suction valves from their defendo valve kits are sticking and not releasing the mucosa resulting in procedure delays.No report of injury.

• Brand Name: DEFENDO DISPOSABLE SUCTION VALVE
• Common Device Name: SUCTION 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 ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 15718858
• Report Number: 1651395-2022-00027
• Device Sequence Number: 7185964
• Product Code: ODC
• UDI-Device Identifier: 00677964055911
• UDI-Public: 00677964055911
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 11/02/2022

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: 100315
• Device Lot Number: 558513
• 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: 10/05/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown