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

Model Number	BF-1TQ180
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
Event or Problem Description
It was observed during the device inspection, that the bronchovideoscope exhibited the plastic distal end cover was burnt.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information was added to the following fields: h3, h4, h6.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, the event concerning the burnt c-cover is likely to occur if a high-energy endotherapy accessory is used without sufficient distance from the distal end.The additional event of the missing bending rubber, we could not specify the root cause of this event.We could not obtain the answer on whether the user used a high-energy endo therapy accessory despite repeated requests.Therefore, we could not make a judgment.The event can be prevented by following the instructions for use (ifu) which state:.Operation manual_ preparation and inspection_ inspection of the endoscope inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Operation manual_ using endo therapy accessories_ high-frequency cauterization.Treatment: warning: never emit high-frequency current before confirming that the distal end of the high-frequency endo therapy accessory is in the endoscope¿s field of view.Also, confirm that the electrode section and the mucous membrane in the vicinity of the target area are at an appropriate distance from the distal end of the endoscope.If the high-frequency current is emitted while the distal end of the endo therapy accessory is not visible or too close to the distal end of the endoscope, patient injury, bleeding, and/or perforation as well as equipment damage can result.*operation manual_ using endo therapy accessories_ argon plasma coagulation (apc) warning: make sure that the distal end of the apc probe always lies more than 10 mm from the endoscope¿s distal end.The protrusion by 10 mm or more can be identified when the first black ring on the apc probe¿s distal end is visible in the endoscopic image.Otherwise, the treated region cannot be irradiated correctly, and the endoscope may be damaged.*operation manual_ using endo therapy accessories_ laser cauterization warning: to avoid patient injury, burns, bleeding, perforation and/or damage to the endoscope, never emit laser radiation before confirming that an appropriate distance between the target and the endoscope¿s distal end is maintained and the tip of the laser probe is surely in the correct position in the endoscopic image.Caution: allow the tip of the laser probe to cool down before pulling it from the channel.If the laser probe is withdrawn while hot, channel damage may occur.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20552980
• Report Number: 9610595-2024-22106
• Device Sequence Number: 3200443
• Product Code: EOQ
• UDI-Device Identifier: 04953170339349
• UDI-Public: 04953170339349
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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-1TQ180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2010
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown