MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II BRONCHOVIDEOSCOPE

Model Number	BF-Q180
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bronchovideoscope's plastic distal end cover was found burnt during the inspection by a third party distributor.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective complaint review involving bf series scopes.This report reflects olympus' re-evaluation of previous medical device reporting decision.The device was returned to a third party distributor and the reported issue was identified during their inspection.The device was not returned to olympus for evaluation.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 third party investigation, it is likely that high-energy hand instruments (laser/high-frequency/etc) were used without ensuring sufficient distance from the distal end.A definitive root cause cannot be identified.The suggested event can be detected and prevented by handling the device in accordance with ¿chapter 4 operation¿ in the instructions for use.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20673499
• Report Number: 9610595-2024-23325
• Device Sequence Number: 8941069
• Product Code: EOQ
• UDI-Device Identifier: 04953170288937
• UDI-Public: 04953170288937
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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-Q180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2023
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2011-2023 AND Z-0189-2
• Patient Sequence Number: 1
• Patient Sex: Unknown