MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. SUCTION VALVE

Model Number	MH-443
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-443- suction valve(button).
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and g2.Please see updates to g2, h6 and h10.The accessory was not returned for evaluation, however, based on the results of the investigation, it¿s likely the brush (mh-507) was used instead of the cleaning brush (bw-20t) specified in the instruction manual, so it could not be inserted.Mh-507 has longer bristles compared to bw-20t, so the resistance is very heavy, but it is possible to pass through.Additionally, it¿s likely that the brush part that can be inserted has deteriorated and the resistance has decreased.The root cause of this event was unable to be identified.The event can be prevented by following the instructions for use which specifies the cleaning brush to be used when cleaning the endoscope, including the accessories.Olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION 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: 15291115
• Report Number: 9610595-2022-01281
• Device Sequence Number: 7167097
• Product Code: FDS
• UDI-Device Identifier: 04953170071256
• UDI-Public: 04953170071256
• 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): 11/01/2022

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-443
• 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: 10/03/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/01/2022
• 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-CHANNEL CLEANING BRUSH
• Patient Sex: Unknown