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); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Fujifilm determined the root cause to be the accidental use of the dc-06d distal end cap, which is not compatible with the ed-580xt.The facility staff was retrained on the instructions for use.

Event Description

On (b)(6) 2022, fujifilm corporation was informed of an incident that occurred during a procedure while utilizing ed-580xt.It was reported that the cap was missing when the scope was withdrawn after the procedure was completed with ed-580xt.The doctor utilized a gastroscope and performed a gastroscopy to locate the cap.They could not find the cap and upon withdrawal of the gastroscope, the cap was found in the patient's mouth.The cap was removed from the patient's mouth, and no injury was observed or reported by the doctor or nursing staff.There was no death or injury reported with this event.

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.

• 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: 14747104
• MDR Text Key: 294390411
• Report Number: 3001722928-2022-00015
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04547410359299
• UDI-Public: (01)04547410359299
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K191747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• 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: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2018
• 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