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

Model Number	BF-MP160F
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
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 8 of 8 reports.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.

• 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: 9816412
• Report Number: 2951238-2020-00371
• Device Sequence Number: 1828320
• Product Code: EOQ
• UDI-Device Identifier: 04953170289064
• UDI-Public: 04953170289064
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2020
• Report Date (Section F): 02/24/2020

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?: Yes
• Distributor Facility Aware Date: 02/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2020
• 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