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

Model Number BF-XP260F

Device Problems Leak/Splash (1354); Peeled/Delaminated (1454); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegations were confirmed.The device evaluation found due to a cut on switch number 1, water tightness was lost, and the connecting tube had a dent.Additionally, the connecting tube had coating peeling off.Due to damage on the channel tube, forceps could not be inserted smoothly.Due to damage on the channel tube, channel cleaning brush could not be inserted smoothly.And the bending tube was damaged due to physical stress.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, it is possible that the reported leak and component defects found during investigation were due to physical stress after years of usage.However, a definitive root cause of the suggested reported event could not be established.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported air/water leakage from the switch and issue with the insertion tube on the evis lucera bronchofibervideoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: the coat of the image guide pipe has been peeled off.There were no reports of patient or user harm associated with this event.

• Brand Name: EVIS LUCERA BRONCHOFIBERVIDEOSCOPE
• 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: 17985854
• MDR Text Key: 326319225
• Report Number: 9610595-2023-15657
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-XP260F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2015
• 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