MAUDE Adverse Event Report: FUJIFILM CORPORATION EC-760S-V/L; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EC-760S-V/L
Medical Device Problem Codes	Break (1069); Crack (1135); Peeled/Delaminated (1454); Material Separation (1562); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref comp #(b)(4).
Event or Problem Description
On june 5th, 2025 fujifilm healthcare americas corporation was informed of an event involving ec-760s-v/l.It was reported that the shifted channel would not allow a biopsy forcep to advance past the problem area during a case, resulting in a delay.Had to withdraw the broken scope and use another scope to return to the area that needed biopsy's this report is being submitted in an abundance of caution due to the unconfirmed patient impact by switching scopes to complete the biopsy.No additional information was provided.

• Brand Name: EC-760S-V/L
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei- machi; ashigarakami-gun, kanagawa 00258 8538; JA 002588538
• MDR Report Key: 22386707
• Report Number: 1000513161-2025-00027
• Device Sequence Number: 7101267
• Product Code: FDF
• UDI-Device Identifier: 14547410397649
• UDI-Public: (01)14547410397649(11)241001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/02/2025
• Report Date (Section F): 06/13/2025

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: EC-760S-V/L
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown