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

Model Number	ED-580XT
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ref (b)(4).
Event or Problem Description
On june 26th, 2024, fujifilm healthcare americas corporation was informed of an event involving ed-580xt.It was reported that metal objects were pulled through during a diagnostic procedure.The patient had a metal stent stuck/impacted and obstructing their bile duct that needed to be cut and broken into pieces in order to be removed.Due to this patients difficult altered anatomy it wasn't feasible to remove the scope multiple times from the patient and remove the metal pieces without pulling them through the channel and risking damaging the scope.The metal object which was involved, that was 'little pieces of metal wire from the broken biliary stent.The scope did not malfunction, it worked well during the entire procedure.Patient was normal state of health.Procedure was able to finish successfully.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL ED-580XT
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 19773288
• Report Number: 1000513161-2024-00036
• Device Sequence Number: 18181249
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2024
• Report Date (Section F): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: ED-580XT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown