D
Patient 1
A MICROKNIFE WAS USED FOR THERAPEUTIC PURPOSES. DURING THE PROCEDUE, THE NEEDLE BROKE OFF INSIDE OF THE PT'S DUODENUM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO COMPLICATIONS OR INTERVENTION REPORTED WITH THIS EVENT.
MAUDE MDR 653978
- MDR report key
- 653978
- Report number
- 6000048-2005-00195
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-08-11
- Date received
- 2005-12-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NANCY CUTINO
- Address
- ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760 US
- Phone
- 508-508-5086
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MICROKNIFE | SECURING | BOSTON SCIENTIFIC | EMF | * | 3281 | 7675612 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-12-14 | 0 |