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

Model Number	BF-1TH190
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported an unspecified time frame after a bronchoscopy procedure using an evis exera ii ultrasonic bronchovideoscope, the patient developed an exophiala lecanii-corni infection.The customer states there are trying to determine if there is a correlation between the scope and the infection.Numerous attempts have been made to gather additional details regarding the reported event with no response from the customer/risk department.
Event or Problem Description
The indication for the bronchoscopy was abnormal computerized tomography (ct) scan with bilateral lower lobe atelectasis.Respiratory culture results: light growth streptococcus, alpha hemolytic fungal: exophiala salmonis / exophiala cancerae.Course of illness (physician visits): pulmonologist: (b)(6) 2021- hospital/scope f/u.Still complaining of shortness of breath (sob), cough, wheezing.Pulmonologist: (b)(6) 2021- (b)(6) -consult - medication changes.Pulmonologist: (b)(6) 2021-still complaining of sob, wheezing improving.Pulmonologist: (b)(6) 2021- 2 week follow-up (f/u), wheezing/sob significantly improved.Pulmonologist: (b)(6) 2021-f/u continues to improve.Pulmonologist: (b)(6) 2021 rochester pulmonologist consult- discussed improvements.Primary care physician (pcp): (b)(6) 2021- increased sob/wheezing, recommended to go to emergency room (er), patient refused.Pulmonologist: (b)(6) 2021: has had worsening asthma.Prednisone 50 mg started.Pulmonologist: (b)(6) 2021- continues with uncontrolled asthma.Continues with cough, wheezing, sputum.Pulmonologist: (b)(6) 2021: peak flow now at baseline.Feels her symptoms are now well controlled at this time.The patient received routine treatment bactrim 3x week) no documentation found related to treatment of fungal culture.Current condition is described as back to baseline.
Event or Problem Description
Correction to g3 of the initial medwatch.The aware date should be 17-mar-2021.

• 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: 11641953
• Report Number: 2951238-2021-00313
• Device Sequence Number: 19595354
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022
• Report Date (Section F): 03/17/2021

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-1TH190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 05/21/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/21/2021; 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: 51 YR
• Patient Sex: Female