MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EG-760R; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EG-760R
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a result of inspecting the subject scope by fujifilm, the endo clip was removed from the channel, and the condition of the channel was found to be fine.There were also no problems with the images.The bleeding from the gastric body that occurred after the biopsy was not caused by the subject endoscope.During the hemostasis procedure, the physician's incorrect operation caused the endo clip to get stuck in the endoscope's channel, which caused a slight delay in viewing bleeding site and taking treatments for the bleeding afterwards.The patient who had bleeding after a biopsy from the gastric body, was transferred to another hospital for further evaluation.It is unclear whether this delay caused by the malfunction had any impact on the patient's condition or outcome.
Event or Problem Description
It was reported that during a endoscopic procedure, an endo clip accidently deployed into the scope to control a bleed.The clip was later retrieved during manual cleaning.This delayed the procedure by three minutes while the scope was replaced.The patient who had bleeding after a biopsy from the gastric body, was transferred to another hospital for further evaluation.The screen was red and would not clear despite using "window washing" resulting to inability to see during case.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EG-760R
• Common Device Name: GASTROSCOPE 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: 21397450
• Report Number: 3001722928-2025-00010
• Device Sequence Number: 9208297
• Product Code: FDS
• UDI-Device Identifier: 04547410358667
• UDI-Public: (01)04547410358667(11)240701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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): 02/18/2025

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: EG-760R
• 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: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown