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

Model Number	ED-580XT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref comp # (b)(4).
Event or Problem Description
On august 15th 2024 fujifilm healthcare americas corporation was informed of an event involving ed-580xt.It was reported that a stent previously stuck in channel, came out in patient.There was no patient harm or injury reported.There was no delay.Procedure was able to finish.A stent fell into the patient stomach and it was retrieved after two weeks.No other information is provided.
Event or Problem Description
The customer believes that on august 2nd, a stent got stuck in the channel of the scope during a procedure and did not come out of the scope.On august 15, the customer noticed and retrieved the stuck stent, then informed fujifilm healthcare america corporation of the incident.On august 22, the customer confirmed that the stuck stent did not fall into a patient's stomach.No patient harm or injury was reported.There was no delay in the august 2nd procedure and it was able to finish.This supplement #1 is being submitted to correct that the stent did not come out in patient; and that the stent did not fall into the patient stomach.
Additional Manufacturer Narrative
Ref comp #(b)(4).

• 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: 20216577
• Report Number: 1000513161-2024-00038
• Device Sequence Number: 15422985
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024
• Report Date (Section F): 09/13/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 09/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/13/2024