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

Model Number	BF-UC180F
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ess (endoscopy support specialists) discussed which cleaning brushes were required to properly reprocess the bf-uc180f with the facility assistant director of perioperative services.In addition, the ess performed the reprocessing in-service with the facility staff.All models were reviewed during the in-service listed in the products section of the users¿ manuals.Ess gave a cds (clean disinfect sterilize) in-service on the bf-uc180f and to the staff utilizing the scope.Ess discussed and demonstrated the reprocessing steps from precleaning through the brushing of the endoscope channels.The ess recommended that the customer follow all olympus reprocessing procedures as documented in the reprocessing manual, explained the importance of each which was acknowledged by all staff in attendance.To date there are no other issues reported.No patient infection reported.
Event or Problem Description
Olympus ess (endoscopy support specialist) was made aware that the customer is unaware of required cleaning brushes used in manual cleaning of the bf-uc180f.There was no patient involvement on this reported event, no known patient infection reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, it is presumed that the reported phenomenon was due to users handling issue.As stated on the ifu (instruction for use) the user manual states: failure to properly clean and high-level disinfect or sterilize endoscope equipment after each procedure can compromise patient safety.To minimize the risk of transmitting infectious agents from one patient to another, after each procedure the endoscope and the equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization, as described in chapter 7, ¿cleaning, disinfection, and sterilization procedures¿.Reprocess not only the external surface of the endoscope but also all channels.All channels of the endoscope, including balloon channel where existing, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.Olympus will continue to monitor complaints 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
• MDR Report Key: 11310689
• Report Number: 8010047-2021-02504
• Device Sequence Number: 19124255
• Product Code: PSV
• UDI-Device Identifier: 04953170341830
• UDI-Public: 04953170341830
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1