MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2020-03-11 for FUJIFILM DUODENOSCOPE ED-580XT N/A manufactured by Fujifilm Corporation.
| Report Number | 3001722928-2020-00007 |
| MDR Report Key | 9820185 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Manufacturer City | ASHIGARAKAMI-GUN, 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 DUODENOSCOPE |
| Generic Name | ENDOSCOPE |
| Product Code | FDT |
| Date Received | 2020-03-11 |
| Model Number | ED-580XT |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-11 |