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

Model Number BF-1T260

Device Problems Defective Component (2292); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found foreign object came out of forceps channel likely due to insufficient cleaning.Due to wear of the angle wire, bending angle in up direction did not meet the standard value.An abnormal sound was made due to the damage on the angulation lever.The objective lens had a crack.The distal end had a crack.Due to dirt on light guide bundle, illumination was uneven.The bending tube was deformed.The universal cord had a scratch and a dent.The connecting tube had a wrinkle and a dent.The customer later confirmed that they cleaned, disinfected, and sterilized the product before returning it for evaluation, and that they were not sure what the foreign material which came out of the scope forceps channel was.They have stated that there were abnormalities in the accessories used for reprocessing.However, the customer failed to elaborate any further.They did confirm that they¿ve presoaked the endoscope in detergent solution, they wiped the nozzle with clean lint-free cloths/brushes/sponges, and they flushed the air/water nozzle with detergent solution.There were no other concerns regarding the reprocessing.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

The customer reported defects of the bending section and insertion tube of the evis lucera bronchovideoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: foreign object came out of forceps channel.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 could not be identified.The root cause of the foreign material remaining in the subject device was unable to be specified.The event can be detected and prevented in accordance with the following instructions for use (ifu).Ifu states that detection method in bf-260 operation manual chapter 3 "preparation and inspection".Ifu states that preventive measure in bf-260 reprocessing manual chapter 3 "cleaning, disinfection, and sterilization procedures".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: 18476731
• MDR Text Key: 332451847
• Report Number: 9610595-2024-00524
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2010
• 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