MAUDE Adverse Event Report: MEDIVATORS ENDOSCOPE DOUBLE ENDED CLEANING BRUSH; CLEANING BRUSHES FOR ENDOSCOPE

Model Number	100402
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2016
Additional Manufacturer Narrative
The facility reported using a medivators disposable double ended channel/valve cleaning brush during the manually cleaning process on a pentax egd endoscope.During the next procedure, it was discovered that one end of the brush with the larger brush diameter had broken off the channel cleaning device and got stuck in the suction channel.The product ifu states that the mechanical attachment of the brushes to the plastic sheath of can not be guaranteed to be reliable.Thus, it is the handlers responsibility to ensure both brushed ends are intact after removal from brushing an endoscope channel.The facility did not follow instructions.Also note, the double ended brush is not intended to be pulled thru the endoscope.One brush end should be entered, then brushed the entire length of the endoscope, and then pulled back in the same direction.The large diameter brush is intended for brushing the valve stem openings.There were no reported patient illness or injury.This complaint will continue to be maintained within medivators complaint system.
Event or Problem Description
A facility reported that an endoscope channel brush end was reported stuck in the suction channel in a pentax egd scope and was not discovered till after the endoscope was used on a patient.

• Brand Name: ENDOSCOPE DOUBLE ENDED CLEANING BRUSH
• Common Device Name: CLEANING BRUSHES FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• MDR Report Key: 6097643
• Report Number: 1651395-2016-00005
• Device Sequence Number: 672046
• Product Code: MNL
• UDI-Device Identifier: 00677964060632
• UDI-Public: 00677964060632
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 11/11/2016

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: No Information
• Device Model Number: 100402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTAX EGD SCOPE