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  

Manufacturer Narrative

The bronchovideoscope was cultured, but there was no growth.The scope was not ethylene oxide (eto) sterilized.Non-olympus detergents were used on the endoscope.The minimum effective concentration is being checked after each cycle in the automated endoscope reprocessor (aer).The aer used is non-olympus.The endoscope channel is being brushed during manual cleaning with a single use brush.Pre-cleaning is performed immediately after a procedure.The endoscope is stored in a non-olympus endoscope drying cabinet.An olympus endoscopy support specialist (ess) visited the customer site on (b)(6) 2024.Based on the observation summary report from the ess, there were no reprocessing deviations observed during the on-site visit.The ess provided a reprocessing in-service or reprocessing training to the user facility staff.The ess provided the user facility staff reprocessing training materials for their reference.To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00162.

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
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18842200
• MDR Text Key: 336960900
• Report Number: 9610595-2024-04643
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335198
• UDI-Public: 04953170335198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• 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