D
Patient 1
DURING A CABG, CORONAY ARTERY BYPASS GRAFT, SURGERY, THE SURGEON WAS USING A SAW WITH A SAW GUARD TO OPEN THE CHEST. THE SAW GUARD BROKE INTO PIECES. ALL PARTS WERE RETRIEVED AND THERE WAS NO INJURY TO THE PATIENT.
MAUDE MDR 588525
- MDR report key
- 588525
- Report number
- 588525
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-03-10
- Date received
- 2005-03-29
- 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 | * | STERNUM BLADE GUARD | STRYKER INSTRUMENTS | LXZ | 4107-8 | * | * | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-03-29 | 0 |