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

Model Number EN-450T5/W

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Ischemia (1942)

Event Date 02/08/2013

Event Type  Injury  

Manufacturer Narrative

The opinion of the doctor who reported the information on the three cases is that: the ischemia could have been triggered by prolonged pressure of a balloon applied to the hepatic portal region (where the hepatic artery and portal systems are running).In addition, a trans-oral entry of the scope and prone position, and, in particular, increased pressure of the body under general anesthesia could increase the risk of developing ischemia.According to the information reported to date by the reporting doctor, the events could be related to the facts that patients were children, the procedures were performed under general anesthesia, the patients were in prone position, and the scopes were inserted through the mouth.Please refer to the attached report.These events are still under investigation at (b)(4).The investigation will assess these factors as potential causes.A supplemental report will be submitted when additional information is available and the investigation is concluded.[(b)(4)].

Event Description

This report is in regards to one (case 1) 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 procedures were performed under general anesthesia and in a prone position.This particular case reported in this mdr, case 1) references site a and regards a pediatric patient with peutz-jeghers syndrome.The following are additional details of this case: the purpose of the procedure was to perform a polypectomy, which was completed.After the procedure, hepatic enzyme levels of the patient increased: ast level went up to 6336 iu/l and alt4398 iu/l.The patient did not complain about any discomfort in particular after the procedure although she vomited several times.The following day she developed a fever (37c), vomited several times, and complained about stomach pains intermittently.In response to that, iv, resting, and fasting were ordered, which led to prolongation of the hospital stay.The patient recovered and was discharged on (b)(6) 2013.The events are still under investigation at (b)(4).

Manufacturer Narrative

Investigation status [view of the physician who treated the patient]: it was probably caused by the compression from the weight of the patient who was in a prone position under general anesthesia.In particular, children can be more vulnerable than adults as children's body such as rib cage is underdeveloped.No dbe under general anesthesia and prone position has been performed since the event.Assessment of the subject device: following the event on (b)(6) 2013, the facility requested servicing of the device on march 26, 2013.The device was inspected and repaired, but no particular abnormalities which could lead to a health hazard were found.It appears that dbe under general anesthesia and prone position affected the event, and it is unlikely that the device failure was the cause of the event.Assessment of the cause of the event]: the physician who notified fujifilm of this event, the physicians who conducted procedures in this case and an anesthesiologist were interviewed.Based on the information gathered, possible root causes were considered but a definite root cause could not be identified.General anesthesia and prone position lower the heart rate and compress the descending aorta reducing blood flow in the mesenteric blood vessel.Trans-oral dbe compresses the hepatic portal, and prolonged air delivery increases internal pressure, reducing blood flow in the mesenteric blood vessel.Liver transplant and patient's pre-existing conditions.Pediatric patients who are more anatomically vulnerable compared to adults (although the event could occur also in adults); the assessment is that these affected the blood flow to the liver and caused hepatic ischemia.If there is any additional relevant information provided a supplemental report will be submitted.

Event Description

On (b)(6) 2013, a pediatric patient with peutz-jeghers syndrome received a trans-oral dbe (double balloon endoscopy) in a prone position under general anesthesia.The patient had undergone multiple treatments before since the first treatment in 2007.The polypectomy treatment, the purpose of the procedure, was completed.However, values of liver enzyme, ast and alt, increased to 6336 iu/l and 4398 iu/l respectively after the procedure.Also, after the procedure, the patient vomited several times but did not voice any complaint of worsening physical conditions.On february 9, 2013, the patient developed a fever (37 celsius degrees), vomited several times, and complained about intermittent abdominal pain.Treatment of the patient: the patient was treated with infusion, fast and rest.The treatment extended the hospitalization period from the original schedule.The patient later recovered and was discharged on (b)(6) 2013.

• Brand Name: EN-450T5/W
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 7629420
• MDR Text Key: 112026664
• Report Number: 3001722928-2018-00053
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EN-450T5/W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 13 YR