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

Model Number BF-P190

Device Problem Leak/Splash (1354)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

During an in-service for reprocessing of the bronchovideoscope for a new technician in the endoscopy department, the endoscopy service specialist (ess) pulled a scope from drying cabinet and upon inspection found it had a leak.There was no associated patient infection reported.

Manufacturer Narrative

The endoscopy support specialist (ess) completed the in-service.The ess provided and reviewed the proper leak testing protocol to the new employee to avoid this happening in the future.All models reviewed during the in-service and all cleaning, disinfection, and sterilization information was reviewed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was added that the scope was not used on a patient.

Manufacturer Narrative

Updated fields: b5, h6, h10.Corrected fields: d9 (device was inspected by an olympus entity).E3 was inadvertently selected and could not be left blank, therefore e3 will contain the data from the initial.This report is being supplemented to provide additional information based on the legal manufacturer's investigation and information received from the customer (b5).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over eight years since the subject device was manufactured.Based on the results of the investigation, it is likely that there was a difference in recognition on device handling or reprocessing steps between olympus recommendation and the user facility.User can prevent the suggested event by following the ifu below: bf-p190 endoscope reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories)." olympus will continue to monitor the field performance of 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: 18339501
• MDR Text Key: 330705009
• Report Number: 9610595-2023-19698
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342110
• UDI-Public: 04953170342110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-P190
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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