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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T ENTEROSCOPE AND ACCESSORIES

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FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T ENTEROSCOPE AND ACCESSORIES Back to Search Results
Model Number EN-580T
Device Problem Misassembly by Users (3133)
Patient Problem Laceration(s) (1946)
Event Date 05/11/2020
Event Type  Injury  
Event Description
On may 26, 2020, fujifilm medical systems usa was made aware of an adverse event during use with a fujifilm en-580t double balloon endoscope. The event occurred at a hospital facility in colombia, where the balloon of the en-580t became over-pressurized with water after the hospital staff erroneously connected the en-580t to an irrigation device; as a result the patient's gastrointestinal mucosa was lacerated. The fujifilm en-580t and the balloon controller are compatible with the fujifilm ty-06 connection tube. However, the hospital staff chose to use fujifilm ty-04 connection tube which is not intended to be used with the en-580t; the ty-04 and ty-06 connection tubes have different connection shapes. The patient was hospitalized and required surgery, no additional information was provided. There was no death associated with this case. This report is being submitted in abundance of caution. During an internal review, it was identified that this event was not reported to fda by the importer as required by 21 cfr 803. This event was reported to the manufacturer and the manufacturer reported this event to fda under report # 3001722928-2020-00009.
 
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Brand NameFUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T
Type of DeviceENTEROSCOPE AND ACCESSORIES
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun
kanagawa 258-8 538
JA 258-8538
MDR Report Key12445952
MDR Text Key270540040
Report Number1000513161-2021-00014
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEN-580T
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/26/2020
Device Age2 YR
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/09/2021 Patient Sequence Number: 1
Treatment
FUJIFILM CA-606 BALLOON CHANNEL CLEANING ADAPTER; FUJIFILM TY-04 CONNECTION TUBE; FUJIFILM TY-06 CONNECTION TUBE
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