MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM 600 SERIES ENDOSCOPE EG-600WR V2; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	FUJIFILM 600 SERIES ENDOSCOPE EG-600WR V2
Medical Device Problem Codes	Partial Blockage (1065); Suction Failure (4039)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/19/2025, fujifilm healthcare americas corportation was informed of an event involving eg-600wr v2.It was reported that the loaner scope was sent with faulty suctioning.The customer had poor suction quality and insufflation abilities.The scope had to be switched out mid- procedure.The provider indicated this could potentially cause harm to patients.Due to unknown the patient harm, fujifilm healthcare americas corportation is reporting this event in an abundance of caution.Ref complaint number (b)(4).

• Brand Name: FUJIFILM 600 SERIES ENDOSCOPE EG-600WR V2
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigara kami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 23784920
• Report Number: 1000513161-2025-00032
• Device Sequence Number: 4989927
• Product Code: FDS
• UDI-Device Identifier: 04547410337402
• UDI-Public: (01)04547410337402(11)170701
• Combination Product (Y/N): N
• 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): 12/11/2025
• Report Date (Section F): 12/11/2025

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: FUJIFILM 600 SERIES ENDOSCOPE EG-600WR V2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/11/2025