MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE COMBINATION CLEANING BRUSH; SINGLE USE SINGLE-ENDED CLEANING BRUSH

Model Number	BW-412T
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the single use single-ended cleaning brush was defective.Several times the customer noted a thread on the brush that may become detached and lodged in the scope.This was discovered during preparation for a colonoscopy procedure, and there was no report of patient harm.This report is linked to the following patient identifiers: (b)(6).
Additional Manufacturer Narrative
The device was not returned to olympus, and it is not expected to be returned for evaluation of the reported issue.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The manufacture date cannot be identified.A review of device history records over the past year prior to the event date and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Replication testing was performed using an olympus endoscope (gif-xp160, serial no.(b)(6)) and bw-412t brush.The channel-opening cleaning brush was inserted into the suction cylinder until the brush part was hidden.It was then rotated counterclockwise repeatedly.Slack in the wire strands at the center of the brush was observed, and bristle loss was confirmed.The reported event was replicated and was likely caused by the aforementioned mechanism.However, the subject device was not returned, so the exact cause of bristle loss could not be determined.The bw-412t instruction manual does not contain a description of missing bristles of the brush.However, the instruction manual of the endoscope (cleaning, disinfection, and sterilization) contains the following descriptions which can prevent the event: "brushing the suction cylinder: when inserting the channel-opening cleaning brush into the suction cylinder, do not forcibly insert the brush beyond the middle of the brush section.Otherwise, the brush may become stuck in the suction cylinder.1.Insert the channel-opening cleaning brush into the suction cylinder as illustrated by c in figure 3.22, until half of the brush section is inserted.2.Turn the inserted brush once.3.Pull the brush out and clean the bristles with your fingertips in the detergent solution.4.Repeat until all debris is removed." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE COMBINATION CLEANING BRUSH
• Common Device Name: SINGLE USE SINGLE-ENDED CLEANING BRUSH
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18268229
• Report Number: 9614641-2023-01849
• Device Sequence Number: 7900239
• Product Code: MNL
• UDI-Device Identifier: 04953170297427
• UDI-Public: 04953170297427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: BW-412T
• Device Lot Number: GK7775T407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown