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

Model Number	EG-760R
Medical Device Problem Codes	Leak/Splash (1354); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On october 31st, 2023, fujifilm healthcare americas corporation was informed of an event involving eg-760r.It was reported that the scope has a buckle or gouge in the distal working channel.There is also a leak in the working channel discovered upon insepction.A second air leak test was performed and the damage was confirmed on the borescope inspection.The damage to the working channel was suspected during a balloon dialation.The md could not get the balloon to advance out of the distal tip of the scope.Another scope and another balloon had to be retrieved as the balloon got bent up in the damaged scope.The patient spent more time under anesthesia as another scope had to be retrieved and another balloon had to be opened and prepped in another room.Due to extend time under anesthesia, the report is being submitted in an abundance of caution.No other additional information was provided.

• Brand Name: FUJIFILM GASTROSCOPE 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
• MDR Report Key: 18234798
• Report Number: 1000513161-2023-00080
• Device Sequence Number: 3306217
• Product Code: FDS
• UDI-Device Identifier: 14547410358664
• UDI-Public: (01)14547410358664(11)210901
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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
• Device Model Number: EG-760R
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown