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

Model Number	BF-1T180
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the evis exera ii bronchovideoscope had leakage inside the instrument channel and the plastic distal end cover burnt or melted around the instrument channel at the distal end.The issue was found during a therapeutic biopsy procedure.There were no reports of patient harm.
Event or Problem Description
The reported issue was found after the procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the device evaluation and the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over nine (9) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the investigation results, it was found that during the use of an endo therapy accessory for high-frequency cauterization, leaked current flowed through the patient via the light guide lens end of the device, causing the flow of high-frequency current in the patient.From the investigation it is presume that the deterioration of the glue filled between the distal end and the plastic distal end cover/probe cover led to poor insulation performance.The event can be prevented by following the instructions for use which state: "-operation manual 3.2 inspection of the endoscope 9.Inspect the objective lens and light guide lens at the distal end of the endoscope¿s insertion section for scratches, cracks, stains, gaps around the lens, or other irregularities." 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: 18572217
• Report Number: 9610595-2024-01518
• Device Sequence Number: 8492420
• Product Code: EOQ
• UDI-Device Identifier: 04953170308215
• UDI-Public: 04953170308215
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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-1T180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2015
• 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