FDA Adverse Event
Malfunction
Summary report: N
PLASMAJET CUT/COAGULATION HANDPIECE
MDR report key: 2721389
·
Received April 30, 2012
Report
- Report Number
- 3004754983-2012-00001
- Event Type
- Malfunction
- Date Received
- April 30, 2012
- Date of Event
- April 5, 2012
- Report Date
- April 30, 2012
- Manufacturer
- PLASMA SURGICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K080197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PLASMAJET HANDPIECE USED SUCCESSFULLY IN LAPAROSCOPIC SURGERY CASE ON (B)(6) 2012, BUT FAILED AT THE END OF THE PROCEDURE WITH INTERMITTENT SPUTTERING OF PLASMA AND DISTILLED WATER OBSERVED FLOWING FROM THE HANDPIECE TIP. PT RECEIVED PROPHYLACTIC ANTIBIOTIC THERAPY. IN F/U ON (B)(4) 2012, IT WAS REPORTED THAT THE PT REQUIRED NO ADDITIONAL TREATMENT AND SHOWED NO EVIDENCE OF COMPLICATIONS ARISING FROM THIS INCIDENT. THIS INCIDENT IS REPORTED ON THE BASIS THAT SHOULD SUCH A FAULT RECUR, THER IS A RISK OF INFECTION FROM THE LEAKAGE OF NON-STERILE DISTILLED WATER USED AS A COOLANT IN THE PLASMAJET HANDPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMAJET CUT/COAGULATION HANDPIECE | NEUTRAL PLASMA SURGERY SYSTEM | GEI | PLASMA SURGICAL INC. | 40028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |