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

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.

• Brand Name: FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T
• Type of Device: ENTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 12445952
• MDR Text Key: 270540040
• Report Number: 1000513161-2021-00014
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 14547410335245
• UDI-Public: (01)14547410335245
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• 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 Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EN-580T
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2020
• Device Age: 2 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FUJIFILM CA-606 BALLOON CHANNEL CLEANING ADAPTER; FUJIFILM TY-04 CONNECTION TUBE; FUJIFILM TY-06 CONNECTION TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR