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

Model Number	BF-UC180F
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.Visual inspection was performed on the received condition and was unable to find any signs of missing parts/black pieces with the scope.The biopsy channel was also inspected with the boroscope and no signs of missing parts/black pieces were noted inside the channel.The scope passed the leak test.In addition, there is bluish discoloration on the distal end probe tip.The reported event could not be confirmed.There were no product problems found.The event was most likely not caused by this device.
Event or Problem Description
Olympus received a complaint stating the during a clean out bronchoscopy procedure, a piece of a black plastic was found in the patient.The clean out procedure was performed after an endobronchial ultrasound (ebus) case was performed on the patient with a different scope.The ebus was initially being performed for a separate reason and the patient had no symptoms related to the foreign body neither before or after the case.The foreign material was removed during the clean out bronchoscopy.The foreign object was tested and the results of testing identified the object non-human tissue.The patient had no complications or injuries after the procedure was completed.The patient did not require any follow up treatment as it relates to the foreign material.This complaint captures 2 of 2 complaints for this reported event.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device was visually inspected and multiple broken fibers were found on the image oes.Additionally, a dent was found at the insertion tube, scratches on the control body and surface scratches on the light guide tube.

• 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: 10047427
• Report Number: 8010047-2020-02659
• Device Sequence Number: 14165323
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 04/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 06/21/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1