MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-22 for EI-530B N/A manufactured by Fujifilm Corporation.
[112030930]
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) (fujifilm, (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.
Patient Sequence No: 1, Text Type: N, H10
[112030931]
This report is in regards to one (case 2) 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. This particular case reported in this mdr, case 2) references site b: a 5(b)(6) year old 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 affected endoscope model in this case was ei-530b, which is not cleared in the us but is a model similar to the us cleared model en-580t; therefore, this case is being reported in an abundance of caution. The exact date of this event is unknown, but is believed to be between the year 2012 and 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001722928-2018-00054 |
| MDR Report Key | 7629516 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-22 |
| Date of Report | 2018-12-10 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SAFETY OFFICER OFFICER |
| Manufacturer Street | 798 MIYANODAI KAISEI-MACHI |
| Manufacturer City | ASHIGARAKAMI-GUN, KANAGAWA 258-8538 |
| Manufacturer Country | JA |
| Manufacturer Postal | 258-8538 |
| Manufacturer G1 | FUJIFILM CORPORATION |
| Manufacturer Street | 798 MIYANODAI KAISEI-MACHI KAISEI-MACHI |
| Manufacturer City | ASHIGARAKAMI-GUN, KANAGAWA 258-8538 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 258-8538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EI-530B |
| Generic Name | ENDOSCOPE |
| Product Code | FDA |
| Date Received | 2018-06-22 |
| Model Number | EI-530B |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM CORPORATION |
| Manufacturer Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JA 258-8538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-22 |