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 2019-05-09 for FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T N/A manufactured by Fujifilm Corporation.
[144589008]
Physician's comment: there was no device malfunction or abnormalities associate with the endoscope during the procedure. Immediately after this incident, the same endoscope was used for a double-balloon procedure and showed no device malfunction or abnormalities. The patient had been taking steroids for a long time since her teens and had severe adhesions in the digestive tract, making it difficult to insert an endoscope. The severe adhesions were also confirmed at the time of the surgery. In addition, the intestinal tract was weakened by intestinal (b)(6). These factors combined may have led to the perforation. Manufacturer evaluation: there was no device malfunction or abnormalities associate with the endoscope. The cause of the perforation is considered as the doctor's opinion.
Patient Sequence No: 1, Text Type: N, H10
[144589009]
Fujifilm was informed that a duodenum perforation was discovered post a double-balloon endoscopy procedure with a fujifilm endoscope. The indication for this procedure was to locate hemorrhagic spots in a patient with intestinal (b)(6). The double-balloon endoscopy began with oral insertion of the scope in order to locate bleeding spots in the patient who had intestinal (b)(6) and had received steroids for a long time since her teens. During insertion of the scope, an x-ray was taken as needed. Approximately 30 minutes into the procedure, passing the scope further became difficult because of severe adhesions. The insertion was aborted in the upper jejunum, and the scope was removed. No abnormalities were found at the time of removal. An x-ray taken post removal of scope revealed that the contrast medium used during the procedure and free-air had leaked to the retroperitoneal side, indicating perforation in the duodenum. At the discretion of a surgeon, the patient had a surgery the following day, and was admitted to the icu (intensive care unit). As of the date of this report, the patient is recovering in a (b)(6) ward and getting better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001722928-2019-00007 |
| MDR Report Key | 8595959 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Manufacturer Street | 798 MIYANODAI KAISEI-MACHI |
| Manufacturer City | ASHIGARAKAMI-GUN, KANAGAWA 002588538 |
| Manufacturer Country | JA |
| Manufacturer Postal | 002588538 |
| Manufacturer G1 | FUJIFILM CORPORATION |
| Manufacturer Street | 798 MIYANODAI KAISEI-MACHI |
| Manufacturer City | ASHIGARAKAMI-GUN, KANAGAWA 002588538 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 002588538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T |
| Generic Name | FUJIFILM DOUBLE BALLOON ENDOSCOPE, PRODUCT CODE: |
| Product Code | FDA |
| Date Received | 2019-05-09 |
| Returned To Mfg | 2019-04-22 |
| Model Number | EN-580T |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM CORPORATION |
| Manufacturer Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 002588538 JA 002588538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-09 |