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

Model Number	BF-XP160F
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bronchoscopic procedure (on a 3-year-old patient weighing 16.4 kilograms), the bronchovideoscope produced a complete blackout and no image could be produced.The event occurred during preparation for use while the patient was under anesthesia.The procedure was delayed by 30 minutes and completed by replacing with another similar device.There were no reports of patient harm.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-sh, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 19505685
• Report Number: 2429304-2024-0000304
• Device Sequence Number: 14457874
• Product Code: EOQ
• UDI-Device Identifier: 04953170340116
• UDI-Public: 04953170340116
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024
• Report Date (Section F): 05/29/2024

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-XP160F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2024
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Unknown
• Patient Weight: 16 KG