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

Model Number BF-1TH190

Device Problem Fire (1245)

Patient Problems Burn(s) (1757); 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.

Manufacturer Narrative

The device was returned to olympus for evaluation.Upon inspection of the returned device, it was discovered that the distal end of the failed the insulation test.The distal end cover was found to have charred marks and was melted and burned along one of the light guide (lg) section.The bending section rubber (a-rubber) of the device was found to be separated from a portion of the distal end with exposed metal.An electrical continuity conducted and resulted in an unstable reading indicating device failure.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is submitted to provide additional information.Updates: b5, d10 and h6.A review of the device history record confirmed that the subject scope was shipped in accordance with the specifications.Based on the results of the investigation and the device evaluation, it is likely that the following led to the malfunction: combustion occurred during laser cauterization for ¿o2 (accelerant) was too high¿ which led to occurrence of the event.A definitive root cause cannot be determined.This issue is addressed in the instructions for use (ifu): the ifu states on possible combustion if laser cauterization is performed with supplying oxygen.Olympus will continue to monitor for the field performance of this device.

Event Description

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 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): 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16328842
• MDR Text Key: 309093824
• Report Number: 9610595-2023-02030
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335181
• UDI-Public: 04953170335181
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LASER FIBER; LEONARDO DUAL 100 DUAL / BIOLITEC (WISDOM MEDICAL)
• Patient Outcome(s): Other; Required Intervention