| Report Number | 3001722928-2019-00006 |
| MDR Report Key | 8601204 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2016-11-08 |
| Date Added to Maude | 2019-05-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| 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 | 0 |