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

Model Number ED-580XT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Esophagus (2399)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

As a result of checking the manufacturing and shipping records of the distal end cap (dc-08d, lot#13540) used during the procedure, no problems were confirmed.Additionally, as a result of inspecting the subject duodenoscope, no malfunctions that could lead to perforation were found.At this time, it is unknown what caused the perforation.If the additional information that can clarify the cause in the future is available, a supplemental mdr will be submitted.

Event Description

On (b)(6) 2023, fujifilm corporation was informed of an event involving ed-580xt.It was reported that the patient had a tear/performation after attempting to pass scope through the esophagus.The doctor noted that he is accustomed to using the olympus scopes.Recently during the procedure, he perforated the esophagus ((through and through).He indicated there was resistance before the scope was pushed further and he immediately used a egd scope to inspect.The patient required additional procedure and placement of stent.There is no patient death associated with the 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 (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
• Type of Device: DUODENOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• 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: 17690457
• MDR Text Key: 322730744
• Report Number: 3001722928-2023-00047
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ED-580XT
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female