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

Model Number	EG-760R
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fujifilm confirmed a small fragment of plastic that had fallen into the patient's body and was recovered.This small fragment was considered to be a piece of a transparent wrapping bag and not a component of the endoscope.It is possible that a piece of some kind of wrapping bag was introduced into the scope channel before or during the procedure, but the cause could not identified.
Event or Problem Description
On april 5th, 2024, fujifilm 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.The procedure was completed successfully.No harm or injury to the patient was reported.

• 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: 19219655
• Report Number: 3001722928-2024-00015
• Device Sequence Number: 12796731
• 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
• 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): 05/01/2024

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
• 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: 04/05/2024
• Initial Report FDA Received Date: 05/01/2024
• 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