MAUDE Adverse Event Report: FUJIFILM CORPORATION EI-530B OR EI-580BT; ENTEROSCOPE AND ACCESSORIES

Model Number EI-530B OR EI-580BT

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

Patient Problem Ischemia (1942)

Event Type  Injury  

Event Description

This report is in regards to one (case 3) of three separate cases reported on (b)(6) 2018, to have occurred in (b)(6); where pediatric patients developed hepatic ischemia after a trans-oral dbe or dberc procedure.In all the cases the liver enzyme values (ast and alt) increased to more than 1000 after the procedure, the procedure was performed under general anesthesia and in a prone position.The affected endoscope model in this case is believed to be ei-530b or ei-580bt.These models are similar to the us cleared model en-580t, therefore, this case is being reported in an abundance of caution.This particular case reported in this mdr, (case 3) references site c and is very similar to case 2: a pediatric patient who had undergone living liver transplantation received a trans-oral dberc (double balloon enteroscope - retrograde cholangiopancreatography) in a prone position under general anesthesia and developed hepatic ischemia.The details and the date of this event is unknown.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 on (b)(6) 2018.The manufacturer reported this event to fda under report # 3001722928-2018-00055.

• Brand Name: EI-530B OR EI-580BT
• 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: 12445743
• MDR Text Key: 270512339
• Report Number: 1000513161-2021-00011
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EI-530B OR EI-580BT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/12/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention