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	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon was confirmed.Compare with the mh-507 of omsc asset, the bristles of the subject device had been fallen off more.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that it was fond the bristles of the subject device used in about 20 cases were loosened and fell off during the reprocessing.There was no patient injury associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) and the followings were found in addition to the last report which had been done on the initial report of mfr report #8010047-2022-01847.[other findings of the investigation] visual confirmation of the subject device.-it was confirmed that the bristles of the brush had come off.-it was confirmed the bending of the shaft.It was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.[conclusion] it was not possible to identify the root cause of the reported phenomenon.[consideration] from the investigation results, it was presumed that the bending of the shaft was confirmed, and that the bending of the shaft caused the twist that bundles the brushes to open.It was presumed that the bending of the shaft was caused by the application of an external force.If additional information becomes available, this report will be supplemented.

• 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: 13331937
• Report Number: 8010047-2022-01847
• Device Sequence Number: 1594940
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 14R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• 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: 12/27/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown