MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CHANNEL-OPENING CLEANING BRUSH

Model Number	MH-507
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the issue was confirmed.A visual inspection was performed on the received condition.Over fifty (50) percent of the brush bristles were missing from the complained device.The metal portion of the complained device was bent.There were no signs of foreign material, and the green handle appeared normal.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
It was reported to olympus that during reprocessing, the channel-opening cleaning brush lost bristles.The intended procedure was completed.The same device was not used to complete the procedure.No other equipment was replaced.No patient harm reported.This complaint is related to patient identifier: (b)(6) (model # mh-507, serial number: (b)(4)).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.It was confirmed that the brush had lost hair and the shaft was bent.It was likely that this phenomenon was caused by the bending of the shaft, which created a gap in the part where the hair was bundled.Bending of the shaft occurred when an external force was applied to the brush during the first use.Alternatively, it is likely that it was caused by the application of external force during transportation or storage to the facility.The instructions for use (ifu) provides the following guidelines: when inserting the channel-opening cleaning brush (mh-507), the single use channel-opening cleaning brush (maj-1339), or the single use combination cleaning brush (bw-412t) 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.

• Brand Name: CHANNEL-OPENING CLEANING BRUSH
• Common Device Name: CHANNEL-OPENING CLEANING BRUSH
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12263465
• Report Number: 8010047-2021-09669
• Device Sequence Number: 11977079
• Product Code: MNL
• UDI-Device Identifier: 04953170023187
• UDI-Public: 04953170023187
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: MH-507
• Device Lot Number: 0YR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1