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

Model Number	EG-580UT
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a leak at the bifurcation of video/us connector.Also reported a failed culture process with positive finding at the elevator and a second finding (also at elevator) following the subsequent reprocessing.Customer requested service to perform a full product maintenance with this in mind.There was no patient involvement.The following information was provided regarding the results of the culture tests.On (b)(6) 2024, the scope was cultured.Results from the culture grew candida albicans.On (b)(6) 2024 the scope was re-cultured.Positive culture grew klebsiella.
Additional Manufacturer Narrative
Fujifilm corporation will conduct a detailed investigation on the subject endoscope.The supplemental mdr will be submitted if the additional information is available.
Additional Manufacturer Narrative
Fujifilm conducted a detailed investigation around the elevator of the subject scope.As a result, there were no abnormalities that could be signs of contamination.On (b)(6) 2024, the site visit was conducted and the reprocessing and culturing process were checked at the facility.As a result, some deviations were found from the recommended procedures described in the ifu, but fujifilm was unable to identify them as the cause of this issue.On 2024/12/5 and 2024/12/19, fujifilm provided retraining on the reprocessing procedures to the facility.

• Brand Name: FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 20394591
• Report Number: 3001722928-2024-00031
• Device Sequence Number: 6596924
• Product Code: ODG
• UDI-Device Identifier: 04547410349061
• UDI-Public: (01)04547410349061
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: EG-580UT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown