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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation.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.When removing the brush from the packaging, the bristles were messy and a little loose.The brush was passed through the equipment, and it was destroyed.All of the bristles were stuck in the equipment.The brush was one (1) of five (5) in which the same issue occurred.Four (4) of the five (5) brushes were discarded.None of the brushes went through sterilization reprocessing, but rather at the first use, the bristles came out.The sterilization staff knew how to use the brush.It was purchased for a long time.There was no new staff or changes in the process.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 identifiers: (b)(6) (model # mh-507, serial number: (b)(4)).(b)(6) (model # mh-507, serial number: (b)(4)).(b)(6) (model # mh-507, serial number: (b)(4)).(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 dhr review could not be performed as no lot number was reported and there was no device return to inspect for a lot number.If the lot number becomes available at a later date, the dhr shall be reviewed.The root cause could not be conclusively specified.It was likely the issue 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 was likely the issue 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: 12263540
• Report Number: 8010047-2021-09673
• Device Sequence Number: 4860756
• 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): 09/02/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1