MAUDE Adverse Event Report: MEDIVATORS INC DEFENDO SINGLE USE SUCTION VALVE

Model Number	100333
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during three patient procedures including use of a defendo single use suction valve, there was lack of suction resulting in procedure delays.In addition, the suction was leaking when seated and was reported as not being as powerful as previous valves.It was reported that during one of the three procedures, the user was sprayed in the face once with sterile water.All procedures were completed successfully with replacement valves.No report of injury.No medical treatment was sought or administered.
Additional Manufacturer Narrative
The devices subject of the reported event were not returned for evaluation and a lot number of the devices were not provided.Without the returned devices, a root cause could not be determined.Upon further evaluation with the senior product manager, it was determined that the user laid the scopes down flat, causing the water to travel back into the handle and spray from the suction valve.A steris product manager provided in-service training to the user facility on the proper use and operation of the defendo fuji 700 valve kit.The instructions for use for the defendo single use valves with the fujifilm 700 series gi endoscopes gives the following information: states "always wear gloves and other appropriate personal protective equipment while handling, such as gown and face mask.Attach the single use air/water valve to the endoscope's air/water port.Push down, twisting slightly back and forth, until the valve engages.Prior to the procedure, depress single use air/water valve to prime air/water channel.Attach the single use suction valve to the endoscope's suction port.Push down, twisting slightly back and forth, until the valve engages.Prior to the procedure, turn on suction source and check suction by depressing the single use suction valve." no additional issues have been reported.

• Brand Name: DEFENDO SINGLE USE 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: 19226075
• Report Number: 1651395-2024-00015
• Device Sequence Number: 15363744
• Product Code: ODC
• UDI-Device Identifier: 00724995228941
• UDI-Public: 00724995228941
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/01/2024

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: 100333
• Device Catalogue Number: 100333
• 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: 04/03/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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