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 Codes	Suction Problem (2170); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref comp #(b)(4).
Event or Problem Description
On january 3rd 2024 fujifilm healthcare americas corporation was informed of an event involving ec-760r-v/l.It was reported that during a diagnostic procedure the suctions was not working properly.The procedure was prolonged due the physician was unable to suction properly.There was no harm or injury to the patient.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: 18610260
• Report Number: 1000513161-2024-00005
• Device Sequence Number: 16770752
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)220601
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Type of Report: Initial
• Report Date (Section B): 01/30/2024
• Report Date (Section F): 01/25/2024

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: Other
• Device Model Number: EC-760R-V/L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown