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	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject endoscope is in continuous use at the facility, and there is no information that the facility has noted any problems with the endoscope.In addition, fujifilm confirmed that there were no problems with the manufacturing records or shipping inspection results for the distal end cap dc-08d (lot: 13632) in which the event occurred.As with similar events in the past, the event may have been caused by a defective installation of the distal end cap, but the necessary information could not be obtained from the facility and the cause could not be identified.
Event or Problem Description
On february 5th, 2024, fujifilm corporation became aware of a complaint involving dc-08d.It was reported that the patient was in for an ercp (endoscopic retrograde cholangiopancreatography) with laser lithotripsy.Upon completion of procedure when scope was withdrawn, distal end attachment was noted to be missing from scope.Doctor and anesthesia aware.Patient transferred to recovery care area.Patient remained drowsy for extended length of time due to anesthesia for long procedure.About 45 minutes after arriving to recovery, still drowsy, patient coughed up distal end attachment, patient's family member discovered and brought to nurse's attention.

• 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: 18843808
• Report Number: 3001722928-2024-00008
• Device Sequence Number: 7758479
• Product Code: FDT
• UDI-Device Identifier: 04547410359282
• UDI-Public: (01)04547410359282
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 03/04/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• 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: Other
• Patient Age: 47 YR
• Patient Sex: Male