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	08/05/2020
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.The shaft had been bent and stretched.Some bristles on the distal end side had been missing.Some bristles had been crushed.There was the dent on the distal end.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 the reprocess, the user opened the package of the subject device, the user seemed that the bristles of the subject device was positioned to the brush handle side than usual.Therefore the user stopped using the subject device.There was no report of patient injury associated with the event.

• 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: 10476230
• Report Number: 8010047-2020-06062
• Device Sequence Number: 14201003
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: No Information
• Device Model Number: MH-507
• Device Lot Number: 9ZR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1