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

Model Number	BF-1T150
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 for evaluation where the reported event was identified.Based on the results of the investigation, a definitive root cause cannot be identified.The probable cause was the use of high-energy hand instruments (laser/high-frequency/etc) without ensuring sufficient distance from the distal end (handling problem).A device history review revealed no issues that could have caused or contributed to the reported issue.Labeling: this issue is addressed in the instructions for use (ifu): the suggested event can be detected and prevented by handling the device in accordance with ¿chapter 4 operation¿ in ifu.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed that during device evaluation, the bronchovideoscope's plastic distal end cover was burned/melted around the instrument channel outlet at the distal end.There were no reports of patient harm.

• Brand Name: 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: 20644478
• Report Number: 9610595-2024-23085
• Device Sequence Number: 20678875
• Product Code: EOQ
• UDI-Device Identifier: 04953170288968
• UDI-Public: 04953170288968
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: Other
• Device Model Number: BF-1T150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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