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

Model Number	EC-760R-V/L
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The result of inspection of the subject endoscope, it was found that the angle wire guide inside the bending portion was deformed, and the bending angle had decreased.However, it was still possible to operate the bending portion, and there were no problems with the endoscopic image.The causal relationship between the perforation and the endoscope malfunction is unknown.The facility did not indicate that the malfunction of the endoscope was the cause of the perforation.
Event or Problem Description
On june 25th 2025, fujifilm corporation was informed of an event involving ec-760r-v/l via medsun report, (b)(4) from fda.It was reported that, on (b)(6) 2025, during a colonoscopy screening for colorectal cancer, the physician realized that the big wheel part of the scope had broken midway through the procedure.The physician was still able to visualize and withdrew the scope.The scopewas then used to retroflex in the rectum, and after the rectum was visualized, a perforation was noted.The scope was then changed out to an egd scope.The angulation control knob is broken on the device.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-760R-V/L
• 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
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 22583983
• Report Number: 3001722928-2025-00024
• Device Sequence Number: 17278088
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)211201
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EC-760R-V/L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown