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

Model Number BF-Q290

Device Problems Leak/Splash (1354); Poor Quality Image (1408)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the image was normal.The bending cover section was damaged and was leaking.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 Description

An olympus personnel reported on behalf of the customer that the evis lucera elite bronchovideoscope had a noisy image; the bending cover was leaking.The issue was found during preparation before use inspection for a diagnostic bronchoscopy.The procedure was completed with another similar device.There were no reports of delays.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Based on the results of the investigation, it is likely the event occurred because of a conduction failure due to water invasion of the device.A definitive root cause cannot be identified.The event can be detected/prevented by following the instructions for use which state: "important information ¿ please read before use ¦precautions: caution turn the video system center on only when the endoscope connector is connected to the light source.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.¦precautions for 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 (except bf-mp290f) 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 field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18223083
• MDR Text Key: 329217266
• Report Number: 9610595-2023-18202
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-Q290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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
• Treatment: CV-290.