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

Model Number BF-XP290

Device Problems No Display/Image (1183); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis lucera elite bronchovideoscope had no image during reprocessing.There was no delay, injury or death reported to olympus, and the patient was not under anesthesia.There was no procedure involved.During device evaluation, the screen blacked out during angulation due to defective charged coupled unit (ccd) unit.

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's reported issue no image was confirmed.The following findings were also noted during device evaluation: bending tube was deformed, and the instrument channel tube had leakage.Based on the results of the investigation, it is likely that the following led to the malfunction: a definitive root cause cannot be identified.Presumably physical stress was applied to bending section during user handling.It damaged the image sensor unit, leading to no image.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): important information ¿ please read before use.¦warnings and cautions: caution.Turn the video system center on only when the endoscope connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the endoscope connector.Failure to do so can result in equipment damage, including destruction of the image sensor.¦warnings and cautions: disappeared or frozen endoscopic image: warning.Follow the precautions given below.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.3.8 inspection of the endoscopic system.¦inspection of the endoscopic image.Confirm that the wli and nbi endoscopic images are normal.5.1 troubleshooting.If any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2,¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS LUCERA ELITE BRONCHOVIDEOSCOPE
• Type of Device: 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: 18128521
• MDR Text Key: 328369474
• Report Number: 9610595-2023-17114
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-XP290
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1