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

Model Number	ED-580XT
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were several previously reported issues in 2019 and 2020 related to the dc-07d distal end cap falling off the ed-580xt during a procedure.Fujifilm believes this incident is similar to the previous cases and is currently investigating to confirm the root cause.In response to the incidents in 2019 and 2020, fujifilm revised the device labeling to provide clearer and more detailed directions for proper attachment of the disposable dc-07d distal end cap.The revised labeling was distributed with a safety notification to all existing customers in april 2020.This is the first known incident since the revised labeling and safety notification was distributed.This user facility was not a customer at the time of the notification.However, it was confirmed that this facility received training on the proper attachment of dc-07d as part of the installation of the device.
Event or Problem Description
On (b)(6) 2022, fujifilm corporation became aware of an event involving ed-580xt.During an endoscopic retrograde cholangiopancreatography (ercp), the distal cap came off of the subject scope and the cap remained inside the patient.The attending team noticed that the cap was missing after the scope had been removed from the patient.Another endoscopic procedure had to be performed in order to retrieve the cap.The cap was removed without harm or injury to the patient.There was no death or serious injury associated with the event.
Additional Manufacturer Narrative
On june 08, 2022, fujifilm corporation concluded the root cause investigation.It was concluded that since the endotracheal tube was inserted at the same time as the duodenoscope, the diameter of the insertion path became narrow, and it is possible that the situation was such that it was easily caught on the edge of the mouthpiece when the duodenoscope was removed.Similar to the cap issues in 2019 and 2020, the cap was not attached properly, and the edge of the mouthpiece may have caught in the gap and that could lead to the cap being dislodged.As a safety measure, a staff re-training was conducted at the facility on 04/14/22 and fujifilm will continue to monitor the site.
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.3001722928-2022-00007 s1 block g4 indicates that it is a combination product.This is in error.It is not a combination product.

• 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: 14218691
• Report Number: 3001722928-2022-00007
• Device Sequence Number: 5479877
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Notification,Relabeling
• 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?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 06/08/2022; 06/08/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/27/2022; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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