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 device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and found the scope failed leak test from a-rubber tape.The objective lens and insertion tube have small dents and scratches.There are minor scratches on the surface.The listed parts were replaced.The device is fully functional, and returned to the user facility.
Event or Problem Description
The user facility reported that there was an issue with the air/water leakages or fluid invasion.The device failed the leak test.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h4, h6 and h10.The legal manufacturer reviewed the contents of this complaint.It was confirmed that the product was shipped conforming to the specifications.The legal manufacturer reported that the root cause could not be determined.The legal manufacturer reported that the most probably cause for the reported event is the following: regarding the leakage on the a-rubber gluing part, since a tear of the bending section rubber and cracks on the gluing part were confirmed, the phenomenon may have occurred due to the application of external force by handling.Regarding the damage to the insertion section, since fine scratches and discoloration have been observed, the phenomenon may have occurred due to external force or chemicals by handling.The legal manufacturer reported that checking the contents of the instructions for use at the product shipment with respect to the insertion section, the following were confirmed.Important information please read before use: do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.

• 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: 10626444
• Report Number: 8010047-2020-07212
• Device Sequence Number: 3321372
• Product Code: PSV
• UDI-Device Identifier: 04953170355592
• UDI-Public: 04953170355592
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/16/2020

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: 09/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1