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

Model Number	BF-UC180F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, it was noted that the probe unit tip was broken.Additionally, the protector boot under the light guide tube was cut.If additional information is received, a supplemental report will be submitted.
Event or Problem Description
It was reported, that the round distal end of the evis exera ii ultrasonic bronchofibervideoscope separated.No patient harm was noted as a result of this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 investigation, it is likely some external force was added to the distal end, damaging the part and it fell off.The instructions for use have the following statement which can prevent the event: "do not apply shock to the distal end of the insertion section, particularly the ultrasonic transducer and the objective lens surface at the distal end.Visual abnormalities may result.".

• 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: 11067280
• Report Number: 8010047-2020-10906
• Device Sequence Number: 14124358
• Product Code: PSV
• UDI-Device Identifier: 04953170355608
• UDI-Public: 04953170355608
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 12/23/2020
• 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