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

Model Number	EG-760R
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving eg-760r.It was reported that a small fragment of plastic fell out into the patient from the inner channel of the scope when snare was utilized.Plastic was retrieved and isolated.Incident report completed and scope taken out of service.No other information provided.As such, this report is being submitted in an abundance of caution.
Additional Manufacturer Narrative
Ref comp # (b)(6).

• Brand Name: FUJIFILM EG-760R VIDEO ENDOSCOPE
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyandai-gun; ashigarakami-gun, kangawa 258-8 538; JA 258-8538
• MDR Report Key: 19047044
• Report Number: 1000513161-2024-00024
• Device Sequence Number: 20952972
• Product Code: FDS
• UDI-Device Identifier: 14547410358664
• UDI-Public: (01)14547410358664(11)220401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024
• Report Date (Section F): 04/04/2024

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: EG-760R
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown