MAUDE Adverse Event Report: OLYMPUS AMERICA, INC EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number BF-1TH190

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  Injury  

Event Description

The customer reported to olympus that during the procedure, evis exera iii bronchoscope was involved in an airway fire.There were no error messages that were observed as a result of the reported failure.The procedure was not completed and was terminated after the event.Iced saline was applied to the airway and a second device was used to inspect the patient¿s airway after the event and the customer reported no patient harm.A laser from an unspecified manufacturer was also involved in the event.Upon inspection of the returned device, it was observed that the scope has burned on distal end cover (c-body) and light guide (lg )lens.The customer confirmed that the patient was monitored on the intensive care unit (icu) for several days and discharged.Based on the patient¿s follow-up exam with otolaryngology, the patient had normal laryngeal exam despite history of recent airway fire during bronchoscopy.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16659450
• MDR Text Key: 312489038
• Report Number: 2429304-2023-00050
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335181
• UDI-Public: 04953170335181
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/09/2023,03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEONARDO DUAL 100 DUAL/BIOLITEC (WISDOM MEDICAL)
• Patient Outcome(s): Other; Required Intervention