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	Malfunction
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 april 6, 2022, fujifilm healthcare americas 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.

• 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
• MDR Report Key: 14218683
• Report Number: 1000513161-2022-00008
• Device Sequence Number: 12132461
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown