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

Model Number	EG-580UT
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, fujifilm 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.On (b)(6) 2023, fujifilm corporation was informed of an event involving the same eg-580ut.It was reported that the scope failed culturing multiple times.There is no patient involvement, serious injury, or death associated with the event.This report is being submitted due to potential of contamination.
Additional Manufacturer Narrative
When the subject scope was returned for the first time and inspected at the local service center, no signs of contamination were found on the around of the elevator mechanism.Fujifilm is currently conducting another investigation of the scope after receiving second notification from the facility.The supplemental mdr will be submitted if the additional information is available.
Additional Manufacturer Narrative
Fujifilm obtained additional information from the facility and our local service center.On (b)(6) 2023 and (b)(6) 2023, the facility performed culture testing of the subject endoscope and confirmed a positive result in a sample obtained from the elevator recess of the endoscope.The local service center inspected the endoscope sent from the facility, adjusted the elevator of the endoscope, and returned it to the facility.At this time, no signs of contamination were identified on the endoscope.On (b)(6) 2023, the facility reprocessed the repaired endoscope and used it on the patient.And then, the endoscope was reprocessed and culture tested and, as with the first and second culture tests, a sample obtained from the elevator recess was positive.No health damage occurred on the patient.The endoscope re-sent to the local service center from the facility.Fujifilm conducted a detailed investigation of the endoscope.The area around the elevator recess, which was noted to have a positive culture test, was investigated in detail, but no signs of contamination were found, and fujifilm could not determine a root cause of this event.No additional complaints or requests were received from the facility.
Additional Manufacturer Narrative
Updated the section a.Patient information.
Additional Manufacturer Narrative
The udi# listed in d4 was corrected.

• 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: 18271829
• Report Number: 3001722928-2023-00064
• Device Sequence Number: 4006639
• 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: K221952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2024

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: EG-580UT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/14/2024; 03/15/2024; Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 03/13/2024; 03/15/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White