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U.S. Department of Health and Human Services

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

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FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE MODEL ED-580XT; DUODENOSCOPE AND ACCESSORIES Back to Search Results
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  Injury  
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.
 
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.
 
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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
700 konaka-cho
sano city, tochigi 327-0-00
MDR Report Key17162381
MDR Text Key318108949
Report Number3001722928-2023-00033
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04547410359299
UDI-Public(01)04547410359299
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K191747
Number of Events Reported1
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,Followup
Report Date 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
Device Operator Health Professional
Device Model NumberED-580XT
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/24/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received05/24/2023
Supplement Dates FDA Received11/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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