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

Model Number ED-580XT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2023

Event Type  malfunction  

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 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.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL 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: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 17162381
• MDR Text Key: 318108949
• Report Number: 3001722928-2023-00033
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04547410359299
• UDI-Public: (01)04547410359299
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2020
• 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
• Patient Outcome(s): Required Intervention