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

Model Number	BF-Q180
Medical Device Problem Code	Leak/Splash (1354)
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 facility report was verified and found that the a-rubber was cut and detached.As a result to the observed damaged on the device, leak testing was unable to be performed.Additional testing found black dots were observed on the screen resulting in image saturation.The device was serviced and returned to the customer.
Event or Problem Description
The user facility reported a leakage from the distal tip of the device.The reporter stated this was discovered during reprocessing of the device so there was no patient involvement associated to this report.No additional information was provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.Based on the investigation results, external stress (impact such as bumping or dropping, interference with endo-therapy accessory, etc.) caused the c cover to crack and the c cover adhesive to peel off.This could lead to the distal tip leaking.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The ifu (operation manual) warns against applying external stress to the endoscope with the following contents: important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10310885
• Report Number: 8010047-2020-04729
• Device Sequence Number: 859966
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• 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): 01/25/2021

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-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1