MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number BF-Q190

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Pneumonia (2011)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported a patient developed infection with pantoea spp.After use of the bronchovideoscope.Initially, the bronchoalveolar lavage (bal) from the patient's bronchoscopy was not positive for pantoea spp.Two days after the procedure, the patient's sputum was positive for the bacteria and they developed symptoms of rales and increased white blood cell (wbc) count.A computed tomography (ct) of the chest showed opacities and worsening pneumonia.The patient was treated with azithromycin for five days and rocephin for seven days.They were discharged home to see an infectious disease provider as outpatient and reported to still have congestion at the time of this report.The facility cultured the bronchovideoscope, but there was no growth.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 18842165
• MDR Text Key: 336958881
• Report Number: 2429304-2024-00162
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335198
• UDI-Public: 04953170335198
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2024,03/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-Q190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2024
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White