MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE MODEL ED-580XT; DUODENOSCOPE AND ACCESSORIES

Model Number	ED-580XT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On june 2, 2023, fujifilm corporation became aware of an event involving ed-580xt.It was reported that the scope continuously failed weekly cultures.There is no patient involvement, death, or serious injury 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
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 (b)(6) 2021 and (b)(6) 2023, due to fda 483 observations issued to fujifilm corporation on (b)(6) 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.
Additional Manufacturer Narrative
Attempts were made to obtain additional information from the facility via the local service center, but no additional information was obtained and the cause could not be determined.No additional complaints or requests have been received from the facility.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL ED-580XT
• Common Device Name: DUODENOSCOPE AND ACCESSORIES
• 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: 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 17208476
• Report Number: 3001722928-2023-00029
• Device Sequence Number: 5768215
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191747
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2024

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: ED-580XT
• Device Catalogue Number: N/A
• Device Lot Number: 2D127G042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 02/16/2024
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 11/06/2023; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• 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
• 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