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

Model Number	EG-580UT
Medical Device Problem Codes	Residue After Decontamination (2325); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On june 8, 2023, fujifilm corporation was informed of an event involving eg-580ut.It was reported that during preparation a red liquid was observed on the balloon attached to the distal end of the scope.The scope was washed twice with aer, but the red liquid flowed out of the nozzle, and use of the scope was discontinued.There is no patient involvement, serious injury, or death associated with the event.As such, this report is being submitted in an abundance of caution.
Additional Manufacturer Narrative
A supplemental report will be submitted pending investigation results.
Additional Manufacturer Narrative
On (b)(6) 2023, fujifilm corporation concluded the root cause investigation of eg-580ut.The disassembly investigation revealed a clog in the distal end.It was determined that the blood could not be expelled due to the clogged channel even after reprocessing with aer.Therefore, the root cause is concluded to be failure to follow instructions.Fujifilm instructed the facility to check for channel blockage as outlined in the instructions for use.
Additional Manufacturer Narrative
This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• 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 CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 17274415
• Report Number: 3001722928-2023-00035
• Device Sequence Number: 5086190
• Product Code: ODG
• UDI-Device Identifier: 14547410349068
• UDI-Public: (01)14547410349068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: N/A
• Device Lot Number: N/A
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 07/25/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/10/2023; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown