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

Model Number	ED-580XT
Medical Device Problem Code	Mechanical Jam (2983)
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
As for during the two weeks between the stent becoming stuck the endoscope's channel and its removal, whether the subject endoscope was used in clinical or not at the facility, fujifilm was not able to confirm.If a foreign object remains inside the endoscope channel, it cannot be properly reprocessed, and if it is used on another patient in that state, there is a risk of cross-infection.If a foreign object remains inside the channel, it is usually recognized during reprocessing or pre-use inspection, and if the channel is blocked by the foreign object, it is unlikely to be used in clinical because it will interfere with the insertion of the device.However, as we have no information on the type or shape of the stent that remained in the channel, and we have not been able to obtain confirmation from the facility that it has not been used in any other procedure for two weeks, this report is being submitted in abundance of caution.
Event or Problem Description
On august 21th 2024 fujifilm 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 retreived after two weeks.Fujifilm corporation conducted additional hearings at the facility and reconfirmed the incident.A stent used during the subject procedure became stuck inside the endoscope's channel, so the endoscope was removed from the patient in that state.The procedure was completed successfully, and there were no other adverse effects on the patient.The stent that had become stuck inside the endoscope's channel was removed two weeks later at the facility.

• 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 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: 20264156
• Report Number: 3001722928-2024-00028
• Device Sequence Number: 18323650
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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
• 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: 08/21/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown