MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part our investigation, on october 12, 2020, while onsite the ess provided the following recommendations: consistency with completing pre-cleaning at bedside and use of air/water channel cleaning adapter and continuation of flushing of the auxiliary channel.Transporting scopes in a 16x16 inch plastic covered bin.Leak test with the mu-1 and mb-155 after every use and prior to manual cleaning.Dispose of single-use brushes and gauze/sponge used during bedside pre-cleaning and manual cleaning.In addition, the ess performed a reprocessing in-service that included bedside pre-cleaning only as the attendees are not involved in the process of leak testing with mu-1 and mb-155, manual cleaning, scope disinfection/sterilization and storage of the scope.Provided supporting documentation and wall charts.The ess discussed the olympus reprocessing protocol for bedside pre-cleaning for gi and pulmonary scopes with the customer.The device will not returned.
Event or Problem Description
The service center was informed that during an in-service at the user facility with an endoscopy support specialist (ess) it was observed that staff was not using air/water channel cleaning adaptor and were not flushing the auxiliary channel of the scopes at bedside.There was no patient involvement, patient infection or positive device culture.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation, and to correct information provided on the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation and onsite training, it was confirmed that the air/water channel cleaning adapter was not used in the facility and the auxiliary channel was not flushed at the bedside.Instructions for reprocessing were reviewed.As a result of confirming the operation manual, the following verbiage is identified: - chapter 5 reprocessing, general policy, section 5.3 precautions: "warning - failure to properly clean and high-level disinfect or sterilize endoscope equipment after each procedure can compromise patient safety.To minimize the risk of transmitting infectious agents from one patient to another, after each procedure the endoscope and the equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization, as described in chapter 7, 'cleaning, disinfection, and sterilization procedures'.Reprocess not only the external surface of the endoscope but also all channels".

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10962284
• Report Number: 8010047-2020-09964
• Device Sequence Number: 2419875
• Product Code: PSV
• UDI-Device Identifier: 04953170355592
• UDI-Public: 04953170355592
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: BF-UC180F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1