MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	ED-580XT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that elevator is not giving full range of motion (stuck).Scarring of the esophagus occurred with two patients when inserting/removing the scope.
Additional Manufacturer Narrative
As a result of inspecting the subject duodenoscope, the complaint by facility "the elevator is not giving full range of motion (stuck)" was found to be within the device's specifications.In addition, there were no defects such as edges or protrusions on the surface of the insertion portion or the distal end of the duodenoscope that could cause damage to the patient.As there were no defects in the duodenoscope that could cause injury to the patient, and as fujifilm was unable to obtain any additional information from the facility, the cause of scarring could not be determined.The extent of the patients' health damage, whether or not additional medical treatment was required, and the outcome of the cases are unknown.This report is being submitted in an abundance of caution.Since health damage occurred in two patients, two mdrs are being submitted including this report (3001722928-2025-00006).

• Brand Name: FUJIFILM DUODENOSCOPE
• 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: 21310540
• Report Number: 3001722928-2025-00007
• Device Sequence Number: 12987623
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2021
• 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 Sex: Unknown