MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE

Model Number	BF-Q180
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported 19 days post bronchoscopy procedure for the indication of hemoptysis for two months and cough, using an evis exera ii bronchovideoscope, the patient developed a respiratory tract infection with mycobacterium llatzerense.This was diagnosed with bronchial alveolar lavage (bal).It is unknown what treatment the patient required as a result of this infection.The patient's current condition is unknown.
Event or Problem Description
Correction to g3 of the initial medwatch.The aware date should be 25-mar-2021.

• Brand Name: EVIS EXERAII BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11665618
• Report Number: 2951238-2021-00315
• Device Sequence Number: 19601173
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022
• Report Date (Section F): 03/25/2021

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: Health Professional
• Device Model Number: BF-Q180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 12/06/2022
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 116 KG