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

Model Number	BF-MP160F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Viral Infection (2248)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.To date, the ess visit has not been finalized.The scope is being retained at the user facility at this time.An investigation is ongoing to obtain additional information regarding the reported event.This report is to account for patient 4.This event has been reported by the importer on mdr# 2951238-2020-00371.
Event or Problem Description
The service center was informed that four patients contracted a cytomegalovirus infection after undergoing a procedure with the facility¿s bronchoscopes.The user facility reported that these were inpatients in the facility¿s burn or respiratory care unit.The patient samples were sent an independent laboratory and cultured positive.As a result, the user facility acquired a sample of the disinfectant flushed from the scope; however, the culture results are unknown at this.The samples from the scopes are being retained at the facility and refrigerated.The scopes were taken out service at that time; however may have been put back into service due to limited inventory.The patient¿s course of treatment is unknown.This is 7 of 8 reports.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Additional information from the user facility¿s microbiology supervisor states the facility worked with the local epidemiologist from georgia public health as a consult.A risk assessment was performed on these patients.From the risk assessment results these scopes have placed back in circulation months ago.The facility has implemented some extra cleaning measures.There have been no other patient infections since we completed the process.In addition, as part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.The customer has declined this visit.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the lm investigation.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified since the device was not returned.The following possible causes for the reported event are presumed as follows: assumable cause1: cmv may have grown in the device due to irregularity in reprocessing method at the facility.This may have resulted in cross contamination.Assumable cause2: patient infection with cmv was caused by some factor during endoscopy at the facility.The legal manufacturer confirmed via dhr that the subject device was shipped in accordance with specifications.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Common Device Name: BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9816434
• Report Number: 8010047-2020-01744
• Device Sequence Number: 13644244
• Product Code: EOQ
• UDI-Device Identifier: 04953170289064
• UDI-Public: 04953170289064
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BF-MP160F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 05/13/2021
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 08/20/2020; 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other