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

Model Number BF-MP290F

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis lucera elite bronchofibervideoscope had a channel pin hole.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: a foreign material at the distal end.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a foreign material at the distal end.In addition to the reportable malfunction, the following were noted: due to a pinhole on the channel tube, water tightness was lost; the bending section cover had discoloration; the connecting tube had a wrinkle and a dent; due to wear of the angle wire, the bending angle in the up direction did not meet the standard value; because the channel tube was crushed, neither the forceps nor the tube cleaning brush could be inserted; the light guide bundle had breakage; due to damage on the charged coupled device unit, a foggy image occurred; the connecting tube had a dent; the plug unit had a scratch; the grip was deformed; the universal cord had a dent and a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the foreign material was unable to be identified and deviation from instruction for use (ifu) are unknown.Therefore, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The event can be detected and prevented by following the instructions for use (ifu) sections: the detection method is described in chapter 3 preparation and inspection of the bf-mp290f operation manual.Instruction manual bf-mp290f cleaning/disinfection/sterilization chapter 5 preventive measures are described in the reprocessing of endoscopes (and accessories that are reprocessed together).Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE BRONCHOFIBERVIDEOSCOPE
• Type of Device: BRONCHOFIBERVIDEOSCOPE
• 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: 18558406
• MDR Text Key: 333463409
• Report Number: 9610595-2024-01398
• 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,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-MP290F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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