MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD CHANNEL-OPENING CLEANING BRUSH

Model Number	MH-507
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the facility medical staff was cleaning the air/water supply button, suction button with mh-507 (cleaning brush), and the brush could not pass through the hole of the air/water supply button.The olympus representative then informed the customer the correct reprocessing procedure by using the bw-20t channel cleaning brush.The issue found during reprocessing and there was no patient harm, no user injury reported due to the event.This event includes three (3) reports: report with patient identifier (b)(6) (mh-438- air/water valve (button).Report with patient identifier (b)(6) (mh-443- suction valve(button).Report with patient identifier (b)(6) (mh-507-channel port cleaning brush).This report is for report with patient identifier (b)(6) (mh-507-channel port cleaning brush).
Additional Manufacturer Narrative
The subject device was not returned to olympus.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned and evaluated.Evaluation results state it was confirmed that the size of the hole at the tip was larger than the standard.The brush does not pass through the hole in the air/water supply button.Instruction manual confirms that mh-507 is not used for the hole that blocks the finger of the air/water supply button.This location is stated to use the bw-20t.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported event.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the button that was used was not washed according to the procedure in the instruction manual.Olympus will continue to monitor field performance for this device.

• Brand Name: CHANNEL-OPENING CLEANING BRUSH
• Common Device Name: CHANNEL-OPENING CLEANING BRUSH
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15291225
• Report Number: 3002808148-2022-01361
• Device Sequence Number: 11345220
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 17R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MH-438- AIR/WATER VALVEMH-443- SUCTION VALVE
• Patient Sex: Unknown