MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE MODEL ED-580XT; ENDOSCOPE AND ACCESSORIES

Model Number	ED-580XT
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Electrical Shorting (2926)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On march 28, 2022, fujifilm healthcare americas corporation became aware of an adverse event involving ed-580xt.It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) sphincterotomy, the subject scope cut right and burned the duodenum.The performing physician stated that leakage from the tip of the scope during the procedure caused cautery of the duodenal wall.No additional intervention was required and the procedure was completed successfully.Two separate incidents were reported involving separate ed-580xt scopes.This report addresses the second scope with serial # (b)(4).There was no death associated with the event, and the burn was determined to be minor.As such, this report is being submitted in an abundance of caution.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL ED-580XT
• Common Device Name: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 14166907
• Report Number: 1000513161-2022-00007
• Device Sequence Number: 12229611
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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: ED-580XT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown