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

Model Number BF-H190

Device Problem Device Reprocessing Problem (1091)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

Olympus was informed, that the bronchovideoscope was used and left out without bedside cleaning or reprocessing until the next day when it was ¿washed and reprocessed¿.No patient infections or injuries were reported.

Manufacturer Narrative

The device is not expected to be returned.The olympus endoscopy support specialist (ess) emailed the september 2023 customer letter reprocessing/delayed reprocessing procedure, as well the bf-h190 instruction manual and reprocessing manual.The ess explained to the customer that they should read the letter and manuals thoroughly, follow the indicated presoak procedures, and be mindful of the indicated presoak time limitation.They should follow all indicated delayed reprocessing procedures, and if they still have any questions, or if the facility has any doubts regarding the efficacy of the procedures, they should not use the device and contact the technical assistance center (tac) for further discussion.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is like that the event reported as "delay in reprocessing" was caused by the user different differed from olympus recommendation in handling of the subject device/reprocessing steps, causing the suggested event.The event can be detected/prevented by following the instructions for use which state: ifu provides the preventive measures in ¿reprocessing manual: 1.4 warnings and cautions¿.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18898556
• MDR Text Key: 337663960
• Report Number: 9610595-2024-05374
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-H190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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