MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT; ENDOSCOPIC ULTRASOUND SYSTEM

Model Number	EG-580UT
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On october 17th, 2023, fujifilm healthcare americas corporation was informed of an event involving eg-580ut.It was reported that there is an issue occurred with the elevator mechanism.In additional, the scope failed both atp and culturing.There is no patient involvement, serious injury, or death associated with the event.As such, this report is being submitted due to potential of contamination.

• Brand Name: FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18120769
• Report Number: 1000513161-2023-00075
• Device Sequence Number: 6988191
• Product Code: ODG
• UDI-Device Identifier: 14547410349068
• UDI-Public: (01)14547410349068
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/13/2023

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: EG-580UT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• 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 Sex: Unknown