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	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, the ess discussed this reprocessing deviation with the customer and was informed that a new scope buddy that provides suctioning was to be purchased when the suctioning was removed and due to the pandemic it was never purchased.The ess reported that the importance of suctioning the model: tjf-q180v, pcf-h190l and ebus scopes was discussed with the facility¿s endoscopy manager and reprocessing staff.The facility will be purchasing a portable suction into the unit to be used in reprocessing.The device will not be returned.
Event or Problem Description
The service center was informed that during an onsite reprocessing in-service with an endoscopy support specialist (ess), it was noted that scope suction was not being performed.The ess reported that the facility¿s suctioning in the reprocessing area had been removed months ago and there is no suction for any scopes being reprocessed.There was no patient involvement, patient infection or device positive culture reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Please see the updates.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.As a result of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.The legal manufacturer reported that there was a possibility that infection/patient injuries occur due to insufficient cleaning of the device, therefore, for measures against this case, cleaning of the device in accordance with the instruction manual is required.The instruction manual was reviewed by the legal manufacturer and it was found that cleaning methods for the device were described in chapter 7 cleaning, disinfection, and sterilization procedures.

• 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: 10692994
• Report Number: 8010047-2020-07776
• Device Sequence Number: 3059041
• Product Code: PSV
• UDI-Device Identifier: 04953170355592
• UDI-Public: 04953170355592
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/29/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1