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

Model Number	100402
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported the tip of a double ended channel brush broke inside an endoscope as staff was cleaning it.It fell inside a patient during the subsequent patient procedure and the physician retrieved the brush tip with a roth net.No adverse event was reported.The technician was cleaning an endoscope with the channel brush when she pulled it out of the endoscope and noticed the tip was missing from the brush.The technician then cleaned the rest of the endoscope with another brush before moving the endoscope to be reprocessed in their automated endoscope preprocessor.The endoscope was then used on the subsequent patient.During the procedure, the physician inserted forceps into the endoscope and it pushed the broken tip of the brush into the patient.The physician retrieved the brush tip with a roth net and no adverse event was reported.This event was not reported to the medivators account manager until a few weeks after it occurred.After regulatory investigation, the patient is confirmed to be fine from this event with no adverse events.There have been no other reports of the double ended brush tip breaking off inside of an endoscope.The channel brush was not returned for investigation and no lot information was provided by the facility.This will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
The facility reported the tip of a double ended channel brush broke inside an endoscope as staff was cleaning it.It fell inside a patient during the subsequent patient procedure and the physician retrieved the brush tip with a roth net.No adverse event was reported.

• Brand Name: DOUBLE ENDED CHANNEL CLEANING BRUSH
• Common Device Name: ENDOSCOPE CLEANING BRUSH
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 7837888
• Report Number: 1651395-2018-00002
• Device Sequence Number: 13774804
• Product Code: MNL
• UDI-Device Identifier: 00677964060632
• UDI-Public: 00677964060632
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: Other
• Device Model Number: 100402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other