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
Additional Manufacturer Narrative
Fujifilm and fda previously collaborated to investigate the root cause of the mucosal burns.It was determined that the burns were considered minor injuries and recurrence of the issue would not likely lead to a serious injury.However, fujifilm became aware of three total mucosal burn incidents involving the same doctor.As such, fujifilm is submitting this report in an abundance of caution.The other incidents will be reported separately.A safety notice was distributed to all active customers on march 31, 2022 regarding the mucosal burn issue.They were also instructed to ensure that the full proximal end of the wire of the high-frequency device is visualized on the endoscope monitor and to review the user manuals for both the endoscope and the high-frequency device.
Event or Problem Description
On (b)(6), 2022, fujifilm corporation was informed of an incident that occurred during an ercp procedure 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.
Additional Manufacturer Narrative
On may 29, 2022, fujifilm corporation conducted the root cause investigation and scope inspection.The ed-580xt scope was inspected and found to be performing as intended.There were no abnormalities identified within the subject scope that could lead to burns or harm to a patient.In addition, the physician at the affected site stated that no further follow-up from fujifilm was required.Therefore, the original investigation conclusion is confirmed.
Additional Manufacturer Narrative
This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.The inspection was performed by fujifilm healthcare americas corporation (hcus), who is the initial distributor and service provider.

• 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
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 14219707
• Report Number: 3001722928-2022-00009
• Device Sequence Number: 17249891
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/29/2022; 05/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/03/2022; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown