MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, the ess discussed the finding with the facility¿s rt lead and recommended an in service with him on reprocessing and scope handling which would also include extend soaking instructions.While onsite the ess completed the reprocessing in-service and reviewed proper extended soaking, and explained this should be performed on the ebus scope prior to the recommended reprocessing steps.The ess also explained how there was a high potential for bio burden on the this ebus scope.The subject device was not returned to the service center for evaluation.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.
Event or Problem Description
The endoscopy support specialist (ess) reported that during an onsite in-service a complete tour of the procedure room, reprocessing area and storage cabinets was completed with facility¿s endoscopy and respiratory therapy (rt) staff.The ess observed that an ebus scope had been improperly reprocessed and noted a piece of a balloon and a dried substance on the s-body (distal tip) of the device.There was no patient involvement reported.
Additional 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.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the cause incorrect reprocessing was likely due to user error.The following information is stated in the instructions for use which may have prevented the event: " chapter 6 compatible reprocessing methods and chemical agents.6.4 disinfectant solution: if disinfectant solution is reused, routinely check its efficacy according to the manufacturer¿s recommendations.Chapter 7 cleaning, disinfection, and sterilization procedures.7.5 manual cleaning: presoak for excessive bleeding and/or delayed reprocessing.Caution.Follow the steps below only in case of excessive bleeding and/or delayed reprocessing: unnecessary immersions should be avoided.Consecutive extended immersions may damage the endoscope.7.Soak the endoscope for 1 hour at the temperature and concentration recommended by the detergent manufacturer." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12481744
• Report Number: 8010047-2021-11837
• Device Sequence Number: 17096859
• Product Code: PSV
• UDI-Device Identifier: 04953170355608
• UDI-Public: 04953170355608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: BF-UC180F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown