Model Number EI-530B OR EI-580BT |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Ischemia (1942)
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Event Type
Injury
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Manufacturer Narrative
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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)(6)).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.
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Event Description
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This report is in regards to one (case 3) of three separate cases reported on may 25, 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.
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Manufacturer Narrative
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Investigation status [view of the physician who treated the patient]: we could not obtain information on the facility which had this event and could not conduct further investigation.Assessment of the subject device: we could not identify the device used in the event, and it is unknown whether the device had a defect.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: based on the information gathered for the two other similar cases, 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.
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Event Description
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A pediatric patient who had undergone living liver transplantation received a trans-oral dberc (double balloon endoscopic retrograde cholangiography) in a prone position under general anesthesia and developed hepatic ischemia.Liver enzyme values (ast and alt) increased to more than 1000 after the procedure.Treatment of the patient liver transplant was performed again.
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Search Alerts/Recalls
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