MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the light source was not working and there was no light from the light guide lens of the device.The subject device was sent to olympus for evaluation.During inspection and testing, there was no image from the device.This report is being submitted for the malfunction found during evaluation (no image).There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.During inspection and testing, there was no image from the device.A review of the device history record found no deviations that could have caused or contributed to there being no image.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the following are probable causes: blackout of endoscope image due to broken wire or short circuit in the imaging cable, blackout of endoscope image due to short circuit caused by cracked tabs on the imaging circuit board, blackout of endoscope image due to separation of the joint of the imaging circuit board, blackout of endoscope image due to abnormal continuity caused by internal water immersion, blackout of endoscope image due to abnormal continuity of electrical connector or electrical cord, blackout of endoscope image due to connector damage or deformation, or blackout of endoscope image due to lens damage or contamination.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual has sentences similar to the following, which may help to reduce/prevent the issue: inspection of the endoscopic system.Warnings and cautions or precautions.Olympus will continue to monitor field performance for this device.The reported issue (no light from light guide lens) was confirmed during testing.In addition, angulation in the up direction did not meet the standard due to the angle wires becoming longer than normal, and the adhesive on the bending section cover was detached due to chemical/physical stress.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16560469
• Report Number: 3002808148-2023-02604
• Device Sequence Number: 17532976
• Product Code: PSV
• UDI-Device Identifier: 04953170341823
• UDI-Public: 04953170341823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2015
• 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