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

Model Number	EG-760R
Medical Device Problem Codes	Crack (1135); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref comp (b)(4).
Event or Problem Description
On january 9th 2024 fujifilm healthcare americas corporation was informed of an event involving eg-760r.It was reported that foreign debris came out of the channel during the procedure.It was uncertain what came out of accessory channel after experiencing tension when biopsy forceps were passed through.The physician attempted to take routine biopsy from duodenum when he experienced tension getting forceps out of the accessory channel, another biopsy forceps was opened and upon further push, both technician and physician noticed debris coming out.They were only able to take picture of it but unable to retrieve "foreign debris".As such, this report is being submitted in due to unknown impact of debris and the inability to retrieve debris during the procedure.

• Brand Name: FUJIFILM GASTROSCOPE MODEL EG-760R
• Common Device Name: GASTROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18602647
• Report Number: 1000513161-2024-00004
• Device Sequence Number: 2722682
• Product Code: FDS
• UDI-Device Identifier: 14547410358664
• UDI-Public: (01)14547410358664(11)220701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2024
• Report Date (Section F): 01/15/2024

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: Other
• Device Model Number: EG-760R
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female