MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EC-760R-V/L; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EC-760R-V/L
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jet wash channel is too strong and it damaged tissue.The patient remained stable, was discharged, and follow-up confirmed full recovery.Issue resolved when the flow of the endo gator descreased by the customer.
Additional Manufacturer Narrative
Upon inspection of the subject endoscope, foreign object was found clogging the water jet nozzle of the endoscope.The foreign object was removed and discarded, so it could not be identified.Therefore, the cause of the blockage is unknown.While it is possible that the foreign object originated from the patient undergoing the procedure, it cannot be ruled out that the foreign object was already present in the channel prior to the procedure due to insufficient reprocessing before the procedure.As a result, the risk of infection was deemed to exist.However, no cases of infection related to this incident have been reported.This event is being reported in an abundance of caution.In this event, minor mucosal damage occurred.It is possible that the water pressure increased beyond normal levels due to the narrowing of the outlet caused by the foreign object blocking the water jet nozzle of the endoscope.Even if this malfunction recurs, it is believed that any mucosal damage caused by water flow would be limited to superficial, minor damage requiring no treatment, similar to this event.
Additional Manufacturer Narrative
D4 - primary unique device identifier (udi) and h4 - device manufacturer date are added.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-760R-V/L
• Common Device Name: COLONOSCOPE 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: 22393716
• Report Number: 3001722928-2025-00021
• Device Sequence Number: 13043213
• Product Code: FDF
• UDI-Device Identifier: 04547410358681
• UDI-Public: (01)04547410358681(11)230301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172916
• 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,Followup
• Report Date (Section B): 07/09/2025

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: EC-760R-V/L
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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