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

Model Number	EC-760P-V/L
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2025, fujifilm healthcare americas corporation was informed of an event involving ec-760p-v/l.It was reported that during the colonoscopy diagnostic procedure, it appeared to have retroflex unintentionally in the sigmoid colon, which was not allowing the procedure to be completed.Colonoscopy was not completed.Potential sigmoid colon mucosal bruise.During a colonoscopy, the physician encountered difficulty advancing the scope due to multiple diverticula and aborted the procedure; while retracting, the scope became stuck but it was released after patient repositioning and a digital exam, which might potentially result in minor bruise.However, there was no adverse events.The patient remained stable, was discharged, and follow-up confirmed full recovery.The incident is being reported in an abundance of caution as the malfunction could cause contribute to serious injury.

• Brand Name: EC-760P-V/L COLONOSCOPE
• Common Device Name: COLONOSCOPE 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: 21885557
• Report Number: 1000513161-2025-00011
• Device Sequence Number: 8174663
• Product Code: FDF
• UDI-Device Identifier: 14547410368878
• UDI-Public: (01)14547410368878(11)230201
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/22/2025
• Report Date (Section F): 03/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: EC-760P-V/L
• 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: 03/27/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female