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

Model Number	ED-580XT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject duodenoscope was inspected at the fujifilm local service center, and no abnormality was found at the distal end that could lead to the cap coming off.The distal end cap dc-08d in which this incident occurred was not available because it was destroyed at the facility, but fujifilm confirmed that there were no problems with the manufacturing records and shipping inspection results for the lot in question (lot: 13632).As with similar events in the past, the event may have been caused by a defective installation of the distal end cap.The facility was retrained on distal end cap installation to duodenoscope.
Event or Problem Description
It was reported that the patient underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure, and during the withdrawal of the duodenoscope ed-580xt from the patient's body, the distal end cap dc-08d fell off into the patient's mouth.After the procedure, the procedure nurse informed doctor about the distal end cap was missing while doing the bedside cleaning of the duodenoscope.The doctor went back to check on the patient's mouth and removed the distal end cap with gloved hand.There was no report of patient harm or injury.

• 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: 19161833
• Report Number: 3001722928-2024-00014
• Device Sequence Number: 7349207
• Product Code: FDT
• UDI-Device Identifier: 04547410359282
• UDI-Public: (01)04547410359282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: 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: 03/28/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown