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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPE

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FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPE 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  
Manufacturer Narrative
Unknown to allow for a connection between en-580t and ty-04 the hospital staff used a fujifilm ca-606 balloon channel cleaning adapter, doing so changed the connection shape allowing a link with the ty-04 connection tube (not compatible with en-580t). Once connection was established, the hospital staff had mistakenly connected the water tube from the irrigation device via the ca-606 balloon channel cleaning adapter, instead of the air supply. The balloon attached to en-580t was supplied with water from the irrigation device; as the irrigation device did not have pressure control the balloon became over pressurized leading to the adverse event. The air supply tube connection shape part of en-580t is exclusive to connection tube ty-06, therefore preventing the possibility of a connection with the water supply tube from the irrigation device. However, by changing the shape of the connection part of the en-580t by using the balloon channel cleaning adapter ca-606, the user was able to erroneously connect the water supply tube from the irrigation device. The biomedical engineer did not allege that there was a malfunction or repair required for the device, therefore the device was not returned to the manufacturer for evaluation. The cause is being attributed to misuse of the device, because the hospital staff used an incompatible accessory to manipulate the connection and allow for connection with the irrigation device, which caused the overpressure in the balloon leading to patient injury; there was no device malfunction. The hospital staff will be retrained. If any additional relevant information is provided, a supplemental report will be submitted.
 
Event Description
On (b)(6), 2020, fujifilm corporation was informed by fujifilm medical systems usa-latin america representative of an adverse event during use with a fujifilm en-580t double balloon endoscope. The event occurred at a hospital facility in (b)(6), 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.
 
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Brand NameFUJIFILM DOUBLE BALLOON ENDOSCOPE
Type of DeviceFUJIFILM DOUBLE BALLOON ENDOSCOPE
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun,
kanagawa, 00258 8538
JA 002588538,
Manufacturer (Section G)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun,
kanagawa, 00258 8538
JA 002588538
Manufacturer Contact
safety officer
798 miyanodai kaisei-machi
ashigarakami-gun
kanagawa, 00258-8538
JA   002588538
MDR Report Key10137710
MDR Text Key195811148
Report Number3001722928-2020-00009
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K143556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/10/2020 Patient Sequence Number: 1
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