FDA Adverse Event
Malfunction
Summary report: N
EXCEL V
MDR report key: 3263389
·
Received February 12, 2013
Report
- Report Number
- 2954354-2013-00006
- Event Type
- Malfunction
- Date Received
- February 12, 2013
- Date of Event
- January 10, 2013
- Report Date
- February 12, 2013
- Manufacturer
- CUTERA, INC
- Product Code
- GEX
- PMA / PMN Number
- K02226
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEVICE OPERATOR REQUESTED 10MM SPOT SIZE ON THE USER TREATMENT SCREEN, THE DEVICE DID NOT ADJUST THE SPOT SIZE ON THE HANDPIECE DELIVERY SYSTEM TO THE REQUESTED SPOT SIZE OF 10MM BUT INSTEAD MAINTAINED A SPOT SIZE OF 1MM. THE DEVICE OPERATOR USED THE DEVICE TO TREAT FACIAL VESSELS ON A PATIENT. THE AREA PULSED HEALED WITH SOME MILD DISCOLORATION, NOT EXPECTED TO BE PERMANENT. THE USER FACILITY REPORTED ON (B)(4) 2013 THAT THE DEVICE HAD BEEN USED TO TREAT THIS PATIENT IN (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62338 | EXCEL V | POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE: GEX | GEX | CUTERA, INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |