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

Model Number BF-XT190

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A user facility reported to olympus that while performing diathermy in conjunction with the evis exera iii bronchovideoscope, the probe caught fire and the patient sustained a burn in their lungs.The cause of the fire was under investigation at the facility.Additional information about the patient's course and outcome was requested but not received.

Event Description

Additional information indicated that the patient had been discharged after spending an unknown amount of time in the intensive care unit.The burn was clarified to be in the airway, and was treated with cortisone, multiple lavages and repeated bronchoscopies.It was unknown what kind of diathermy device (manufacturer, model) was utilized and its compatibility with the scope.Oxygen at 100% concentration had been used during the diathermy which was stated to be the probable cause of the ignition of the bronchoscope.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b2, b5, h4, h6 in addition to the device evaluation and investigation.Evaluation of the returned device revealed the following findings: leaking of the a-rubber, broken a-rubber with metal exposed, a leak in the biopsy channel, burned c-cover, cracked a-rubber glue, angulation on the control unit was less than the specified value and had play, blurred image and abnormal color tone due to a broken ccu unit, and the scope failed the grounding safety test.We could not specify root cause of the suggested event.Since the event was not reproducible, the suggested event was not confirmed.We presume from the following investigation results that the event occurred as the user used highly concentrated oxygen (100%), which created an environment for the subject device to be ignited easily.·the user used highly concentrated oxygen while using the subject device.·when ignition occurred, oxygen concentration in the patient's airway was 100%.Ifu: bf-190 series operation manual warns in 4.3 using endotherapy accessories laser cauterization as follows: do not perform laser cauterization while supplying oxygen.This may result in combustion during cauterization.Review of the device history record confirmed that the subject device was shipped in accordance with the specifications.The subject device had no nonconformity at manufacturing.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's further investigation.In addition to the instructions for use (ifu) details provided in the previous mdr submission, the reported event can be detected/prevented by also adhering to the ifu as follows: ¿5.1 troubleshooting (countermeasures against abnormality during use of endoscopes).¿ ¿also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient (described in section 5.3 - withdrawal of the endoscope with an irregularity).¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Upon further review of follow up # 1, it was found that in reference to the ifu, it inadvertently referred to laser cauterization instead of high frequency cauterization.The bf-190 series operation manual warns in 4.3 "using endotherapy accessories high-frequency cauterization" as follows: do not perform high-frequency cauterization while supplying oxygen.This may result in combustion during cauterization.

• 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: 16850178
• MDR Text Key: 314349942
• Report Number: 9610595-2023-06947
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170402470
• UDI-Public: 04953170402470
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K183419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-XT190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2020
• 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; Other; Hospitalization