D
Patient 1
DURING THE PROCEDURE IT WAS NOTED THAT THE JAWS OF THE FORCEPS WERE SPRUNG WHILE REMOVING A SPECIMEN FROM THE DEVICE. ALL PARTS OF THE DEVICE WERE PRESENT, BUT THE JAWS WOULD NOT CLOSE.
MAUDE MDR 2559528
- MDR report key
- 2559528
- Report number
- 2559528
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-03-23
- Date received
- 2012-04-27
- 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#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RADIAL JAW 3 | FORCEPS, BIOPSY | BOSTON SCIENTIFIC | BWH | * | M00515231 | 14819365 |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-04-27 | 0 |