MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIR/WATER VALVE

Model Number	MH-438
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
Additional Manufacturer Narrative
The subject device was not returned to olympus.Communication with the customer conveyed that they have corrected the button cleaning process and to use the bw-20t channel cleaning brush and there is no problem that the brush does not pass through the hole of the air/water supply button because it is originally cleaned with the bw-20t brush.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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 opening cleaning brush).This report is for report with patient identifier (b)(6) (mh-438- air/water valve (button).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and because the device was not returned, a definitive root cause could not be determined.However, it is considered that the brush (mh-507) which was not specified in the reprocessing manual was used instead of the specified brush (bw-20t) and the brush (mh-507) could not be inserted.Since mh-507 has longer bristles of the brush compared to bw-20t, the resistance is quite high.However, it is possible to insert mh-507.It was told that some brushes which could be inserted and others not.Though the cause was not specified, it is presumed that the bristles of the brushes which can be inserted may be deteriorated, whose resulted in low resistance.The possibility of the individual variation cannot be identified since the actual item check was unavailable.Olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15290899
• Report Number: 9610595-2022-01280
• Device Sequence Number: 7167089
• Product Code: FDS
• UDI-Device Identifier: 04953170071249
• UDI-Public: 04953170071249
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• 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): 11/02/2022

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-438
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• 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: 10/05/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-507-CLEANING BRUSH.
• Patient Sex: Unknown