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

Model Number	EG-760R
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/19/2026, fujifilm healthcare americas corporation became aware of an event involving eg-760r.It was reported that the polyps keep getting stuck in the channel and the customer has to keep suctioning and pulling out the forceps.Due to unknown patient status, fujifilm healthcare americas corporation is reporting this event in an abundance of caution.The evaluation of the product confirmed that the forceps channel tube was damaged in bending section.Ref: fujifilm healthcare americas corporation complaint # (b)(4).

• Brand Name: 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
• MDR Report Key: 24911156
• Report Number: 1000513161-2026-00009
• Device Sequence Number: 18610427
• Product Code: FDS
• UDI-Device Identifier: 14547410358664
• UDI-Public: (01)14547410358664(11)190501
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EG-760R
• 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?: No
• Distributor Facility Aware Date: 03/19/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown