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

Model Number BF-H190

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fungal Infection (2419); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The customer requested reprocessing in-service due to issues with bronchoscope reprocessing and stated that they have had multiple instances where patient specimens tested positive for penicillium species after bronchoscopy cases.The endoscopy support specialist (ess) performed reprocessing observations at the facility and noted deviations to instructions for use (ifu) reprocessing instructions.During manual cleaning it was noted that the scopes were flushed with detergent solution instead of aspirating.After manual cleaning and rinsing, the scopes were placed in oer-pro reprocessor for reprocessing.This report is being submitted to capture the incorrect reprocessing procedure followed by the site.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The ess was on-site for observations of bedside cleaning with respiratory staff.During observations, the ess noticed that endobronchial ultrasound (ebus) 180 scopes were not having irrigation channel flushed with detergent and same precleaning sponge and detergent mixture was being used on bronchoscope and ebus 180 scope used during procedure of same patient.The ess completed a reprocessing in-service to correct deviations and provided customer with scope cleaning wall charts.The customer stated that they will send in all bronchovideoscope and ebus 180 scopes to olympus service center for scope evaluations for damage.The subject device was not returned.Based on the results of the investigation, the root cause of the incorrect reprocessing was that the user¿s understanding differed from olympus recommendation in device handling and/or reprocessing steps.Re-training for the correct handling was completed.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2023-00286.

Event Description

This event is reported under the following related patient identifiers (b)(6) to capture the multiple instances where patients tested positive for penicillium species.This medwatch report is for patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's further 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 2 years since the subject device was manufactured.Based on the results of the final investigation, the root cause of the reported patient infections could not be determined.Since detailed information regarding the patients was not provided by the customer, a relationship between the subject device and the reported patient infections could not be identified.Furthermore, there is no change to the investigation findings regarding the improper reprocessing that was previously reported.The event can be detected/prevented by following the instructions for use (ifu) in section: ¿reprocessing manual: chapter 5 - preventive measures.Reprocessing the endoscope (and related reprocessing accessories)¿.This supplemental report includes a correction to h6 to provide information that was inadvertently not included on the initial medwatch.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: 17669848
• MDR Text Key: 322488072
• Report Number: 9610595-2023-12606
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• 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: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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
• Patient Outcome(s): Other