MAUDE MDR 50941414
- MDR report key
- 50941414
- Report number
- 3002808148-2026-34275
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-09-02
- Date received
- 2026-09-30
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- Mr. Todd Brill
- Address
- 800 West Park Drive Westborough MA 01581 US
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 418166 | HD CAMERA HEAD | CAMERA HEAD | SHIRAKAWA OLYMPUS CO., LTD. | FET | OTV-S7PROH-HD-L08E | Y | Y | |||||
| 510575 | HD CAMERA HEAD | CAMERA HEAD | SHIRAKAWA OLYMPUS CO., LTD. | FET | OTV-S7PROH-HD-L08E | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-09-30 | 0 |
Event Narratives#
No narrative records found.