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

Model Number ED-580XT

Device Problems Improper or Incorrect Procedure or Method (2017); Electrical Shorting (2926)

Patient Problem Bowel Burn (1756)

Event Date 03/24/2022

Event Type  malfunction  

Event 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 first 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
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 14166902
• MDR Text Key: 295250503
• Report Number: 1000513161-2022-00006
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1