MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The service center was informed that during an onsite reprocessing observation with an endoscopy support specialist (ess) it was noted that the customer not brushing or flushing the suction valve during manual cleaning.The customer was also skipping cleaning steps on the leak testing, air water cleaning adapter, suction valve, air water valve, and biopsy button.There was no patient infection, patient involvement or device positive culture reported.This is report 2 of 3.
Additional Manufacturer Narrative
The device will not be returned to the service center for evaluation.As part of our investigation, on 27may2021, the ess returned to the customer¿s site to provide an in-service with the staff that included: cleaning and disinfecting information as contained in the on-track document.The ess recommended that the customer follow all olympus reprocessing procedures as documented in the on-track forms and reprocessing manuals.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation and lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: the legal manufacturer presumed that the staff was inadequately trained in handling or reprocessing in accordance with ifu.Ifu : operation manual 6.2 manually cleaning the accessories.5 with the channel cleaning brush part of the single use combination cleaning brush(bw-412t) or the channel cleaning brush (bw-20t), brush the interior and openings of the suction valve (mh-443), the air/water valve (mh-438), and the biopsy valve, until debris can no longer be seen.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11967800
• Report Number: 8010047-2021-07301
• Device Sequence Number: 19925282
• Product Code: FDS
• UDI-Device Identifier: 04953170071256
• UDI-Public: 04953170071256
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1