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

Model Number	BF-XP160F
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus facility for evaluation and the customer¿s allegation was confirmed.In addition, evaluation found the following: there was fluid in the objective lens; the image was cloudy, due to the fluid in the lens, the mask was deformed; and there were multiple dents on the insertion tube.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
It was reported that the bronchofibervideoscope image was black.The issue occurred during a preparation for use of a therapeutic and diagnostic procedure.The intended procedure was completed using a similar device.There was a 5 minute while new scope was obtained.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, it is likely that the event occurred due to fluid invasion inside the objective lens causing electrical components to fail.It is likely that that moisture entered the venting connector of water-resistant cap, or distal end glue absorbed moisture.It is also possible that moisture entered the device by attaching/ detaching venting connector/leakage tester tube while water droplets adhered to outer surface of the connector/ inside the tube and its connection, or when they were immersed for a longer time than necessary.The event can be prevented by following the instructions for use (ifu) which state: "ifu (reprocessing manual) states about caution during leakage test as follows: ·never immerse the water-resistant cap unless it is attached to the endoscope.Water remaining inside the water-resistant cap can be transferred to and damage the electrical connector.·always use a dry water-resistant cap.Any water remaining on the water-resistant cap may cause damage to the endoscope, maintenance unit or light source.Ifu (reprocessing manual) states about caution regarding long-term immersion as follows: presoak for excessive bleeding and/or delayed reprocessing: caution follow the steps below only in case of excessive bleeding and/or delayed reprocessing; unnecessary immersion should be avoided.Consecutive extended immersion may damage the endoscope." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• 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: 18587589
• Report Number: 9610595-2024-01701
• Device Sequence Number: 7021595
• Product Code: EOQ
• UDI-Device Identifier: 04953170340116
• UDI-Public: 04953170340116
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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-XP160F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2008
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown