MAUDE Adverse Event Report: OLYMPUS AMERICA, INC 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
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 system, 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.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16710540
• Report Number: 2429304-2023-00059
• Device Sequence Number: 7340481
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2023
• Report Date (Section F): 03/15/2023

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?: Yes
• Distributor Facility Aware Date: 03/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLMD/220-100W/UNKNOWN LOT NUMBER; ENDOTRACHIAL TUBE WITH UNKNOWN MODEL/LOT NUMBERS; POWERED LASERED SURGICAL INSTRUMENT (LOT #226202)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown