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

Model Number BF-260

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported the sheath from the introduction sheath to the distal end of the evis lucera bronchovideoscope was worn.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the bending section cover came off and the coating of the connecting tube was peeled.The report is being submitted due to the defects found during evaluation.

Manufacturer Narrative

Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the leak test and electrical safety test failed due to missing bending section cover, the light guide cover lens was broken, the scope cover was damaged, the connecting tube was dented, the universal cord was buckled and scratched, the connector was corroded, the electrical connector was corroded, angulation was reduced and the suction failed due to the missing bending section cover.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

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 were identified.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that physical stress was applied to the insertion section, causing the coating to peel.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿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.

• 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: 16844014
• MDR Text Key: 314299610
• Report Number: 9610595-2023-06917
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023984
• 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,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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