FDA Adverse Event
Malfunction
Summary report: N
PICOSURE LASER SYSTEM
MDR report key: 3904677
·
Received May 22, 2014
Report
- Report Number
- 1222993-2014-00015
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Date of Event
- April 22, 2014
- Report Date
- May 21, 2014
- Manufacturer
- CYNOSURE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K110907
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS BEING SHIPPED BACK TO CYNSOURE INC FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER REPORTING THE FOOT PEDAL IS LOCKING DOWN AND LASER IS FIRING FREELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306580 | PICOSURE LASER SYSTEM | PICOSURE LASER SYSTEM | GEX | CYNOSURE, INC. | 100-7012-010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |