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

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the insertion tube was found to be peeling, and difficulty was encountered in passing the snare through the scope.Eventually, the snare passed through and a piece of plastic was discovered and retrieved using a roth net.Although the plastic material is biologically safe and poses no health risk, the retrieval created an unplanned medical intervention.
Additional Manufacturer Narrative
Upon investigating the subject endoscope, it was confirmed that there was a scratch and surface peeling at a position 3 cm from the distal end of the endoscope inside the forceps channel.Although difficulty was encountered in passing the snare through the endoscope, eventually, the snare passed through.Based on this information, it is believed that when the snare was forcefully inserted into the forceps channel, the inner wall of the channel was scraped, and the resulting a piece of plastic fell into the patient's body.The piece of plastic that fell into the patient's body were subsequently retrieved using a roth net.As a result, the procedure took longer than expected.The procedure was completed successfully, but an unexpected medical intervention to retrieve the fallen objects occurred.

• 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: 21908224
• Report Number: 3001722928-2025-00015
• Device Sequence Number: 21014788
• Product Code: FDS
• UDI-Device Identifier: 04547410358667
• UDI-Public: (01)04547410358667(11)220401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/25/2025

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
• 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: 03/28/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: Required Intervention
• Patient Sex: Unknown