MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	ED-580XT
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Current leakage from device during sphincterotomy resulting in injury to the duodenal wall and resulting in excess coagulation to the major papilla thus raising the risk of post-ercp pancreatitis.

• Brand Name: FUJIFILM
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 81 hartwell avenue, suite 300; lexington MA 02421
• MDR Report Key: 14955881
• Report Number: 14955881
• Device Sequence Number: 17871209
• Product Code: FDT
• UDI-Device Identifier: 04547410359282
• UDI-Public: 04547410359282
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2022
• Report Date (Section F): 03/29/2022

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
• Device Model Number: ED-580XT
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 03/29/2022