FDA Adverse Event
Summary report: N
PLASMABALDE
MDR report key: 2003940
·
Received February 11, 2011
Report
- Report Number
- 2003940
- Date Received
- February 11, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 11, 2011
- Manufacturer
- PEAK SURGICAL INC
- Product Code
- GEI
- Report Source
- User Facility report
- Reporter Location
- AR, US
Narratives
Description of Event or Problem · 1
DURING A TOTAL KNEE PROCEDURE, THE SURGEON WAS USING THE PLASMA BLADE TO TRIM OFF SOME RESIDUAL CEMENT FROM AROUND THE PLATE. THE POWER BUTTON WAS INADVERTENTLY ACTIVATED. A SMALL "CANDLE" FLAME WAS SEEN, BUT WAS IMMEDIATELY EXTINGUISHED WITH A WET SPONGE. THE SURGICAL SITE WAS IRRIGATED AND UPON INSPECTION, NO TISSUE DAMAGE OR BURN WAS NOTED. THERE IS NO KNOWN PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABALDE | RADIOFREQUENCY DEVICE | GEI | PEAK SURGICAL INC | 4.0 | 34844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | NO OTHER THERAPIES |