MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE ED-580XT; DUODENOSCOPE 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 03/02/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 fujifilm corporation was informed of an incident that occurred during an ercp procedure.During an ercp sphincterotomy the cautery was not functioning correctly and was not cutting the ampulla as intended.The cautery functioned as intended after switching out the electrosurgical unit.After the procedure was complete, the doctor noticed burns in the patient's duodenum adjacent to the ampulla.There was minor blanching of the mucosa with some coagulated blood.The doctor believes that there was current leakage from the cautery.No additional intervention was required.The procedure was completed successfully.There is no death or serious injury associated with event.

Manufacturer Narrative

There were seven previously reported issues of a mucosal burn caused by a sphinctertome wire energizing the distal end of the ed-580xt while in contact with mucosa.The image from this case appears similar to images from the previous cases.Therefore, fujifilm believes that the root cause is the same as the other reported cases.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.As such, fujifilm initially determined this new incident as non-reportable.However, fujifilm became aware of two additional 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 (b)(6) 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.

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.

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 ED-580XT
• Type of Device: DUODENOSCOPE 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: 14142230
• MDR Text Key: 293188869
• Report Number: 3001722928-2022-00008
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1