MAUDE MDR 50941415
- MDR report key
- 50941415
- Report number
- 3002808148-2026-34276
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-06-04
- Date received
- 2026-09-30
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 418168 | EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE | ULTRASOUND GASTROVIDEOSCOPE | SHIRAKAWA OLYMPUS CO., LTD. | ODG | GF-UCT260 | | | | | | Y | Y |
| 442708 | EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE | ULTRASOUND GASTROVIDEOSCOPE | SHIRAKAWA OLYMPUS CO., LTD. | ODG | GF-UCT260 | | | | | | Y | Y |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-09-30 | 0 | |
Event Narratives#
No narrative records found.