MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-25 for FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT N/A manufactured by Fujifilm Corporation.
| Report Number | 3001722928-2019-00015 |
| MDR Report Key | 9241902 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-25 |
| Date of Report | 2019-10-25 |
| Date of Event | 2019-09-30 |
| Date Mfgr Received | 2019-09-30 |
| Device Manufacturer Date | 2016-07-06 |
| Date Added to Maude | 2019-10-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SAFETY OFFICER |
| Manufacturer Street | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN |
| Manufacturer City | KANAGAWA, 002588538 |
| Manufacturer Country | JA |
| Manufacturer Postal | 002588538 |
| Manufacturer G1 | FUJIFILM CORPORATION |
| Manufacturer Street | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN |
| Manufacturer City | KANAGAWA, 002588538 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 002588538 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT |
| Generic Name | ENDOSCOPE |
| Product Code | FDA |
| Date Received | 2019-10-25 |
| Returned To Mfg | 2019-10-09 |
| Model Number | EI-580BT |
| 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 | 2019-10-25 |