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

Model Number BF-MP190F

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/05/2023

Event Type  malfunction  

Manufacturer Narrative

During device evaluation at olympus, it was found the scope had fluid invasion, the control body had corrosion, the image guide fiber had significant breakages, the image was blurry, and the scope case unit was deformed.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported bronchofibervideoscope tested positive for an unexpected contamination.The issue was found during reprocessing.The scope was tested after being received.The scope tested positive and was then tested again.The customer noted that after use, the scope was cleaned by using a syringe to flush it out.The scope was left to dry and when the customer went to use it again, there was still water present.It was unclear if the scope was used in a procedure.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

Corrected fields: h10 (cleaning disinfection and sanitization (cds) practices was inadvertently missed on the initial).This report is being supplemented to provide additional information based on the customer provided cleaning disinfection and sanitization (cds) practices and 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.The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer confirmed that there were no suspected patient infections due to the facility findings.Precleaning was performed immediately after patient procedure.Water was aspirated through the suction channel with a suction pump.The instrument/suction channel was brushed.The forceps elevator was raised and lowered three times when submerged in the detergent solution.The forceps elevator was flushed.The device was rinsed before manual disinfection.All channels were flushed and immersed into disinfectant.The final rinse was with filtered water.The expiration date of the disinfectant was controlled.The water quality of the rinse water was controlled and water filters were replaced in accordance with the instructions for use.The scope was dried with filtered compressed air and stored in a drying cabinet.The scope was sampled after storage and was quarantined when the positive test was confirmed.Additional reprocessing was performed before the device was returned to olympus.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, the reported event could not be confirmed as the scope was not microbiologically tested by olympus.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18254349
• MDR Text Key: 329554272
• Report Number: 9610595-2023-18628
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170395581
• UDI-Public: 04953170395581
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-MP190F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/25/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• 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