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

Model Number	EC-760R-V/L
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref comp #(b)(4).
Event or Problem Description
On march 29th 2024 fujifilm healthcare americas corporation was informed of an event involving ec-760r-v/l.It was reported that leaks were identified at the co2 insufflation connection point and would not allow for bowel insufflation.As such, this report is being submitted in an abundance of caution.No additional information was provided.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 19194107
• Report Number: 1000513161-2024-00030
• Device Sequence Number: 15533981
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)220801
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024
• Report Date (Section F): 04/26/2024

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: Health Professional
• Device Model Number: EC-760R-V/L
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown