MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for FUJINON EN-450T5 manufactured by Fujifilm Medical Systems U.s.a., Inc..
[72367310]
Patient Sequence No: 1, Text Type: N, H10
[72367311]
Procedure: esophagogastroduodenoscopy with double balloon enteroscopy nn: fujinon double balloon scope broke during the procedure. We changed to a second scope. The broken scope was immediately sent out for repair per our protocol. The double balloon enteroscopy procedure has a potential for gastric mucosal injury because of the distance the scope travels into the small intestine and the potential for subsequent looping in the stomach. The scope dials breaking didn't cause the mucosal injury. Correct endoscope fujinon inc. Medical division colonoscope double balloon endoscopy model en-450t5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6479948 |
| MDR Report Key | 6479948 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-01-06 |
| Report Date | 2017-03-10 |
| Date Reported to FDA | 2017-03-10 |
| Date Reported to Mfgr | 2017-03-10 |
| Date Added to Maude | 2017-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJINON |
| Generic Name | ENDOSCOPE, FIBER OPTIC |
| Product Code | GDB |
| Date Received | 2017-04-11 |
| Model Number | EN-450T5 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
| Manufacturer Address | 10 HIGH POINT DR. WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |