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

Model Number	BF-UC180F
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was received for evaluation.Evaluation determined that the forceps passage of the device was found to have a channel leaking.The c-body was detached from the bending section and one broken element was found during image check.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required specifications.
Event or Problem Description
It was reported that during reprocessing, the device was observed to have hole inside the transducer lumen.According to the reporter, prior to the reprocessing where the hole was discovered, the device malfunctioned during a case.The said malfunction occurred at the end of the procedure.The type of malfunction was not provided including the type of procedure being performed.The intended procedure according to the reporter was completed with no impact or harm or the patient.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr), the device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The cause of the event cannot be conclusively determined.Based on the device evaluation findings, the loss of the apical part of the unit has been confirmed and likely, an external force may have been applied to the apical part.As a result of the external force applied to the distal end part, the tip part could not tolerate the load, broke and was dislodged.The reported phenomenon likely attributed to mishandling of the device.Olympus will continue to monitor complaints for this device.

• 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: 10145439
• Report Number: 8010047-2020-03290
• Device Sequence Number: 2924871
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 08/29/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1