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

Model Number	BF-Q180
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/19/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: the following concomitant devices were reported: power lasered surgical instrument with unknown model number/lot number 226202 by photomedex; clmd/220-100w/unknown lot number by photomedex; endotrachial tube with unknown model and lot numbers by covidien.The device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.The user facility medwatch is attached for additional information.This report has also been submitted on importer medwatch report #2429304-2023-00059.
Event or Problem Description
Olympus medical systems corp.(omsc) received a user facility medwatch (b)(4), which reported that during a diagnostic bronchoscopy using an olympus bronchoscope with yag laser procedure using a non-olympus laser machine and fibers, a fire started inside the non-olympus endotracheal tube (ett) during laser ablation of a carinal tumor.The tip of the laser fiber was burned off and apparently lost in the patient.A portion of the ett burned and melted both the bronchoscope and the end of the fiber.Bronchoscopy following the fire was difficult to assess, as there had been extensive laser treatment fulguration prior to the fire.The fire was quickly extinguished and the patient appeared to have sustained minor injury only.It was not clear if the fiber failed first and caught the ett on fire or if the fire started first and melted the fiber.Laser power was set at 15 watts with a duration of 0.5 seconds.The laser was 1064 nm wavelength.The laser machine was tested following the incident and the power output was found within allowable tolerance.The distal end of the damaged fibers appeared to be fractured, but it was not known at what point that this occurred.The fiber used was a contact type that used a sapphire or ruby tip and air cooling.There reportedly have been several failures in the past where the tips burned off and had gotten lost.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the device was not returned for evaluation, and no additional event details could be obtained from the customer.Therefore, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide corrections to e2, e3, g2, h7 and h9 to include information that was inadvertently not included in the previous submissions.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: 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: 16710561
• Report Number: 9610595-2023-05910
• Device Sequence Number: 11187610
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: BF-Q180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 11/18/2024
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 07/31/2023; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2016-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLMD/220-100W/UNKNOWN LOT NUMBER.; ENDOTRACHIAL TUBE WITH UNKNOWN MODEL/LOT NUMBERS.; POWER LASERED SURGICAL INSTRUMENTS (LOT #226202).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown