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

Model Number	ED-580XT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the result of investigation, fujifilm believes that the facility may have made a user error when assembling the caps.It was thought 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.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.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 user facility was not a customer at the time of the notification.Since the lot that the customer purchased did not accompany the revised labeling, this facility received training on the proper attachment of dc-07d as part of the installation of the device.After the occurrence of this incident, our local distributor sent a letter to the facility again to inform them of the proper attachment procedure of dc-07d.
Event or Problem Description
On (b)(6) 2023, fujifilm corporation was informed of an event involving ed-580xt.It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) the distal end cap (dc-07d) detached from the distal end of a duodenoscope and fell into the patient's oral cavity.The cap was extracted by performing an endoscopy.The procedure was completed successfully without harm or injury.There is no death reported with the event.
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 (b)(6) 2021 and (b)(6) 2023, due to fda 483 observations issued to fujifilm corporation on (b)(6) 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL ED-580XT
• Common Device Name: 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: 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 17162381
• Report Number: 3001722928-2023-00033
• Device Sequence Number: 16741072
• Product Code: FDT
• UDI-Device Identifier: 04547410359299
• UDI-Public: (01)04547410359299
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown