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 Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and found following.Some bristles on the distal end side had been missing.The shaft had been bent.There was the dent on the distal end.The shaft had been stretched about 2mm from the specification.There was the foreign material on some bristles.Some bristles had been crushed toward the brush handle.Omsc compared the subject device and the unused device, omsc surmised that the subject device was not unused.Based upon the above, omsc concluded that the reported phenomenon was attributed to the applying the external force such as the hit against something or scratch due to the handling by the user.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during a preparation for the reprocessing, when the user used the subject device for first time, the user seemed that the distal end side of the brush had less bristles than usual and the shaft was exposed.Therefore the user stopped using the subject device.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The aware date should be 29-jun-2020.Olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10481234
• Report Number: 8010047-2020-06095
• Device Sequence Number: 2709427
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 82R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• 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: 08/05/2020
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown