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

Model Number	BL-7000
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On april 15th, 2023, fujifilm healthcare americas corporation was informed of an event involving bl-7000.It was reported that the insufflation appears to be inconsistent, as well as irrigation, during a treatment.There was a 20-minutes delay to troubleshoot the processer and the scope.There was no harm or injury to the patient.As such, this report is being submitted due to delay of procedure.No additional information was provided.
Additional Manufacturer Narrative
Ref comp # (b)(4).

• 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: 19307491
• Report Number: 1000513161-2024-00032
• Device Sequence Number: 20665748
• Product Code: FET
• UDI-Device Identifier: 04547410337730
• UDI-Public: (01)04547410337730(11)190501
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• Report Date (Section F): 05/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: BL-7000
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown