MAUDE Adverse Event Report: MEDIVATORS, INC. DOUBLE ENDED CHANNEL BRUSH

Model Number	100402
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	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report did not identify the name or location of the user facility of the device in question therefore, additional information could not be obtained.To-date we have not been informed of this event directly from the user facility.There was no lot number provided.Should we obtain additional information regarding the user facility or specific device subject of this event, a follow-up report would be filed with the results of our investigation.A review of complaints indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (mw5111956) that their endoscope cleaning brush is not effectively cleaning the scope.No report of patient harm or injury.

• Brand Name: DOUBLE ENDED CHANNEL BRUSH
• Common Device Name: BRUSH
• 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: 15598351
• Report Number: 1651395-2022-00022
• Device Sequence Number: 16723270
• Product Code: MNL
• UDI-Device Identifier: 00677964060632
• UDI-Public: 00677964060632
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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: 100402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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