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

Model Number	MH-507
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that the customer claimed the bristles of the device fell out easily.Other detailed information was not provided.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The device was returned to olympus medical systems corp.(omsc) for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The reported failure was confirmed.The metal shaft at the tip of the brush was bent.The bristles were easy to fell out from the bent shaft.The exact cause was unknown; however, omsc assumed that excessive force applied to the tip may have caused the failure.

• 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: 11376811
• Report Number: 8010047-2021-02979
• Device Sequence Number: 3859558
• Product Code: MNL
• UDI-Device Identifier: 04953170023187
• UDI-Public: 04953170023187
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1