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

Model Number	BF-UC180F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced scope was returned to the olympus service center for evaluation.The service group found the insertion tube was discolored/chemical damage with surface scratches.Additionally, the reported leak at the bending tip was confirmed as a cut was found on the bending section cover.The bending cover was removed and excessive broken bending cover mesh strands were broken.The image was off center, scratches on the distal end cover and the scope connector's back cover was loose.The scope was repaired and returned to the customer.A review of the scope's service history shows the scope was purchased on (b)(6) 2009 and was last serviced via (major) repair on (b)(6) 2020.The investigation is ongoing.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The service center was informed by the user facility that during reprocessing, the evis exera ii ultrasonic broncho-fiber videoscope was found leaking at the bending tip.No patient injury or harm was reported to olympus.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-08641.The oem performed a device history record review and no abnormality was found.The oem completed the investigation and determined that there was no manufacturing, material or processing related cause for this failure mode.Based on the investigation results, the oem determined the most likely cause of the reportable malfunction (peeling of the coating / faded marking at the insertion site of bf insertion tube) is from the following: external forces or handling by chemicals, because fine scratches and discoloration have been observed.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: 10801163
• Report Number: 8010047-2020-08641
• Device Sequence Number: 3372016
• Product Code: PSV
• UDI-Device Identifier: 04953170341823
• UDI-Public: 04953170341823
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2021

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: Other
• Device Model Number: BF-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1