FDA Adverse Event
Malfunction
Summary report: N
ICON
MDR report key: 7041773
·
Received November 17, 2017
Report
- Report Number
- 1222993-2017-00044
- Event Type
- Malfunction
- Date Received
- November 17, 2017
- Report Date
- November 17, 2017
- Manufacturer
- CYNOSURE INC
- Product Code
- GEX
- PMA / PMN Number
- K142376
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN EVALUATED THE DEVICE AND FOUND THE AFFECTED 1540NM ENERGY WAVELENGTH HANDPIECE DELIVERING A VERY LOW ENERGY OUTPUT THAT WAS BEYOND THE +/-20% ACCEPTABLE SPECIFICATION RANGE. TECHNICIAN PERFORMED SEVERAL CALIBRATION TESTS, BUT IT WOULD CONTINUE TO DELIVER A LOW OUTPUT, OUTSIDE OF SPECIFICATION RANGE. SO THIS REQUIRED THE TECHNICIAN TO RECOMMEND A REPLACEMENT FOR THE AFFECTED HANDPIECE TO RESOLVE THE CUSTOMER'S ISSUE. THIS INCIDENT IS REPORTABLE BECAUSE THE DEVICE OPERATED OUT OF SPECIFICATION RANGE.
Description of Event or Problem · 1
THE DEVICE WAS FOUND OPERATING BEYOND SPECIFICATION RANGE, DELIVERING A VERY LOW ENERGY OUTPUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820388 | ICON | ICON | GEX | CYNOSURE INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |