MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPE, EN-450T5, EN450P5; ENTEROSCOPE AND ACCESSORIES

Model Number EN-450T5, EN-450P5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Aspiration Pneumonitis (4455); Pancreatitis (4481)

Event Type  Death  

Event Description

On 8/17/2023, fujifilm corporation became aware of literature involing en-450t5 and en-450p5.Upon reviewing literature, one procedure related death was reported.The exact date of the events is unknown.

• Brand Name: FUJIFILM DOUBLE BALLOON ENDOSCOPE, EN-450T5, EN450P5
• 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: 17802719
• MDR Text Key: 324105644
• Report Number: 1000513161-2023-00067
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EN-450T5, EN-450P5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/29/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Death
• Patient Sex: Male