MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W; ENTEROSCOPE AND ACCESSORIES

Model Number EN-450T5/W

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

Patient Problem Air Embolism (1697)

Event Date 12/01/2023

Event Type  Death  

Manufacturer Narrative

This en-450t5/w has not marketed in the united states.This mdr is submitted because similar device en-450t5(510(k):k183683) was marketed in the united states.There were no abnormalities leading to adverse events in the device used.The physician also did not complain of any abnormality in the device.In patients having undergone surgical (gi) reconstruction, gastrointestinal insufflation pressures may easily increase.This air could have invaded the blood vessels.For this reason, the following is listed in the ifu." in patients having undergone surgical (gi) reconstruction, gastrointestinal insufflation pressures may easily increase without notice and air or gas may enter an injured or damaged blood vessel.Patient conditions should always be carefully monitored.If an embolism is suspected, immediately stop the procedure and take appropriate action.".

Event Description

The patient had congenital biliary atresia and had gastrointestinal reconstruction by kasai surgery shortly after birth.A double-balloon endoscopy was performed to diagnose obscure gastro-intestinal bleeding.During observation of the gastrointestinal tract, the patient's blood pressure dropped, his condition suddenly changed, and he went into cardiac arrest.The patient was resuscitated but died.A ct scan revealed an air embolus.

• Brand Name: FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W
• Type of Device: ENTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: safety officer ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538 ; JA 258-8538
• MDR Report Key: 18585770
• MDR Text Key: 333772203
• Report Number: 3001722928-2024-00007
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EN-450T5/W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian