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

Model Number BF-260

Device Problems Leak/Splash (1354); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the bronchovideoscope connecting tube bending section was leaking.The issue occurred prior to use during pre-use inspection for a diagnostic procedure and the procedure was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction is being made to previously submitted g3 - date received by manufacturer.The correct date was 04/08/2024.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 were identified.The device was returned to olympus for inspection, and the customer's leakage complaint was not confirmed.In addition, the following reportable malfunction was found during the device evaluation: connecting tube has coating peeling (more than 1 mm2).Based on the results of the investigation, it is likely the following led to the malfunction: while the user was handling the device, physical/chemical stress was applied to insertion section which led to occurrence of the suggested event.The event can be detected by following the instructions for use: 3.2 inspection of the endoscope 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor field performance for this device.

Event Description

It was observed that during the device inspection, the bronchovideoscope exhibited the connecting tube had the coating peeling (more than 1 to 2 mm).There were no reports of patient involvement.

• Brand Name: EVIS LUCERA 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: 19059190
• MDR Text Key: 339586737
• Report Number: 9610595-2024-07238
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K023984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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
• Device Operator: Other
• Device Model Number: BF-260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2003
• 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