N
Patient 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
MAUDE MDR 25341009
- MDR report key
- 25341009
- Report number
- 3002808148-2026-18651
- Event key
- 0
- Event type
- 3
- Date received
- 2026-05-31
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 501
- 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
- Phone
- 508-508-5082
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 288048 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE | SHIRAKAWA OLYMPUS CO., LTD. | PSV | BF-UC190F | N | Y | |||||
| 478626 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE | SHIRAKAWA OLYMPUS CO., LTD. | PSV | BF-UC190F | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-05-31 | 0 |
Event Narratives#
D
Patient 0
IT WAS REPORTED THAT THE ULTRASOUND BRONCHOFIBERVIDEOSCOPE DISPLAYED ERROR B30 (SCOPE COMMUNICATION ERROR). THERE WERE NO REPORTS OF PATIENT?S HARM.