MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-760P-V/L; COLONOSCOPE AND ACCESSORIES

Model Number	EC-760P-V/L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On september 25th 2023, fujifilm healthcare americas corporation was informed of an event involving ec-760p-v/l.It was reported that during a diagnostic for colon procedure there was no peripheral vision and decrease lighting.Their procedure took longer to finish.Due to unknown status of patient and equipment, the report is submitted with abundance of caution.There was no injury to the patient reported.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-760P-V/L
• Common Device Name: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 18003172
• Report Number: 1000513161-2023-00071
• Device Sequence Number: 18037854
• Product Code: FDF
• UDI-Device Identifier: 14547410368878
• UDI-Public: (01)14547410368878(11)211101
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: EC-760P-V/L
• Device Catalogue Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown