MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L; COLONOSCOPE AND ACCESSORIES

Model Number	EC-760R-V/L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hcus engineer confirms light is dim because of the dirt that cover the lens.After the clean up, the light became normal and it's not dark anymore.
Event or Problem Description
On september 8th, 2023, fujifilm healthcare americas corporation was informed of an event involving ec-760r-v/l.It was reported that the light source is very dim.The customer has trouble to see if it was a scope light failure or light source failure.It was determined to be the scope light failure.There is no serious injury or death associated with the event.Therefore, this report is being submitted in abundance of caution.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L
• Common Device Name: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 17886716
• Report Number: 1000513161-2023-00069
• Device Sequence Number: 7326999
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)220801
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 10/06/2023

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: EC-760R-V/L
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/08/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown