MAUDE Adverse Event Report: FUJIFILM CORPORATION LIGHT SOURCE BL-7000; ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY

Model Number	BL-7000
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On june 5th, 2025 fujifilm healthcare americas corporation was informed of an event involving bl-7000.It was reported that the staff smelled smoke and burning coming from the eluxeo system, during a treatment.No additional information was provided.The report is being submitted in abundance of caution due to the unconfirmed patient impact by switching scopes during the treatment.
Additional Manufacturer Narrative
Ref comp #(b)(4).
Additional Manufacturer Narrative
Reference complaint #: (b)(4).Update: detailed investigation of the incident concluded that the reported issue was not confirmed.During the investigation, all circuit boards and electrical components were checked and there was no burnt electrical parts found and no catastrophic burning smell detected.The bl-7000 was clean in a new physical condition.It passes all electrical safety tests with no abnormalities and operated per manufacturer specifications.Initial importer mdr 1000513161-2025-00025 is attached in this supplemental report (s1).

• Brand Name: LIGHT SOURCE BL-7000
• Common Device Name: ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei- machi; ashigarakami-gun, kanagawa 00258 8538; JA 002588538
• MDR Report Key: 22387151
• Report Number: 1000513161-2025-00025
• Device Sequence Number: 6979228
• Product Code: FET
• UDI-Device Identifier: 04547410337730
• UDI-Public: (01)04547410337730(11)240401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/30/2025
• Report Date (Section F): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BL-7000
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Event Location: Other
• Date Report to Manufacturer: 07/02/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/02/2025