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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT
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FUJIFILM CORPORATION FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT Back to Search Results
Model Number EG-580UT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Biliary Cirrhosis (1736); Hemorrhage/Bleeding (1888); Perforation (2001)
Event Date 03/15/2021
Event Type  Death  
Event Description
On february 28, 2022, fujifilm healthcare americas corporation was notified of adverse events related to eg-580ut identified during literature review.The referenced scientific literature described 5 procedure-related adverse events, of which 4 resulted in death.The adverse events involved either the fujifilm eg-580ut or the olympus gf-uct180.Specific details of the procedure and the device used are not available, and the exact date of the event is unknown.The relationship between eg-580ut and the aes cannot be found in the report or related literature nor is it confirmed.As such, this case is being reported in an abundance of caution.Since no patient identifiers were provided, one report is being submitted for all five patients.
 
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Brand Name
FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT
Type of Device
ENDOSCOPE
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun, kanagawa 258-8 538
JA  258-8538
MDR Report Key13720724
MDR Text Key286932342
Report Number1000513161-2022-00003
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/10/2022
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? No
Device Model NumberEG-580UT
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/28/2022
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/10/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Death;
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