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

Model Number	EC-760R-V/L
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving ec-760r-v/l.This report addresses the second of three events that occurred at the user facility using the same scope.It was reported that during a procedure the patient experienced a minor colon abrasion that is suspected to have been caused by a sharp point on the distal end.The scope was switched causing a slight delay.Thereafter, the procedure was completed successfully without further incident.There is no death associated with the event.As such, this report is being submitted in abundance of caution.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-760R-V/L
• Common Device Name: GASTROSCOPE 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: 17283346
• Report Number: 1000513161-2023-00040
• Device Sequence Number: 3064386
• Product Code: FDS
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)210201
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/07/2023

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
• 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?: Yes
• Distributor Facility Aware Date: 06/09/2023
• Device Age: 29 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown