MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM; EN-450T5

Model Number EN-450T5

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

Patient Problem Bowel Perforation (2668)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

Fujifilm medical systems u.S.A., inc.(fmsu) was informed on february 2, 2018, that a patient undergoing a double balloon endoscopic procedure using the subject enteroscope and the balloon controller pb-20 required surgical intervention to correct a perforation that occurred during the procedure.Prior to the endoscopic procedure, the balloon controller used to inflate the scope balloon had malfunctioned, but it later started to function and was used at the start of the procedure.However, during the procedure the balloon controller malfunctioned again.This prompted the use of the manual method for inflating the endoscope balloon, using a syringe.Information from the hospital following the incident indicates that the individual that inflated the balloons was not experienced in the manual syringe method that was employed.The subject enteroscope used during this procedure was received at the fujifilm service center for inspection, however, the inspection results indicate that the enteroscope was most likely not a factor in the perforation incident.The subject balloon controller that failed during operation had not been serviced since 2014, although the manufacturer instructions recommend sending the device for inspection every six months or every 100 cases, whichever is first.This device was received for inspection and service at the authorized fujifilm service center with the report that there was no air to the endoscope side.This pump failure was confirmed on february 13, 2018, as the pump was unable to maintain pressure.The enteroscope and the balloon controller are currently in repair and will be returned to the hospital.The location of the perforation was later confirmed to be in the ileum section of the small intestine.The patient was undergoing a therapeutic intervention to stop pre-existing gi bleeding.A physician was operating the endoscope during the procedure, and a nurse was controlling the inflation of the balloon at the instruction of the physician (the nurse operated the balloon controller and syringe).The perforation in the patient was noted immediately as the endoscope was being retrieved from the patient.A surgical intervention was completed successfully at that time.The patient was discharged from the hospital days later.The investigation into the cause of this incident is ongoing.Upon conclusion, additional information will be reported in a follow up report.

Event Description

Fujifilm medical systems u.S.A., inc.(fmsu) was informed on (b)(6) 2018, that a patient undergoing a double balloon endoscopic procedure using the subject enteroscope required surgical intervention to correct a perforation that occurred during the procedure.

Event Description

On (b)(6) 2018, a double balloon endoscopy was performed with the purpose of treating bleeding of digestive tract.Prior to the procedure, a pre-use device inspection was conducted with the balloon pump controller pb - 20, endoscope en - 450 t and balloon bs - 2 connected.At that time balloon dilation failure was confirmed, but the balloon dilation operation was enabled after flushing the balloon channel of the endoscope with air, so the procedure was initiated.However, it became difficult again at that point, to expand the balloon during the procedure.Use of the balloon controller for balloon operation was ceased, switching to manual operation with a syringe to continue the procedure, and a perforation occurred in the ileum of the small intestine of the patient.During the procedure, the doctor operated the endoscope while the nurse operated the balloon (operation of the balloon controller, and operation of the syringe after switching to manual operation).Of note was that the nurse had never performed manual balloon operation with a syringe before.In addition, the procedure was not performed under x-ray fluoroscopy.

Manufacturer Narrative

The perforation was not detected during the procedure.During and after the procedure, abdominal distention was observed.X-ray at the completion of the procedure showed air leakage from the intestinal tract, at which time, surgery was conducted.The patient was discharged on a later date.Considering the situation of the event, it is inferred that the perforation was minute.If the perforation had been caused by over-inflation of a balloon by manually sending air into the balloon with a syringe, the intestinal tract would have been significantly damaged instantaneously and the incidence would have been easily noticed by the operator.So it has been determined that the perforation was not caused by the over-inflation of the balloon but rather by insertion operation of the balloon and the endoscope.Since the subject device does not show any deficiencies which might have led to the perforation, and necessary notes are stated in the operation manuals, it has been determined that new additional measures are not required.Current practice of providing information through attached operation manuals will continue.

• Brand Name: FUJIFILM
• Type of Device: EN-450T5
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 7309259
• MDR Text Key: 101372295
• Report Number: 3001722928-2018-00048
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• PMA/PMN Number: K040048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: EN-450T5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR