FDA Adverse Event
Malfunction
Summary report: N
ELITE+
MDR report key: 5021861
·
Received August 21, 2015
Report
- Report Number
- 1222993-2015-00039
- Event Type
- Malfunction
- Date Received
- August 21, 2015
- Date of Event
- July 7, 2014
- Report Date
- August 21, 2015
- Manufacturer
- CYNOSURE INC
- Product Code
- GEX
- PMA / PMN Number
- K141425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN EVALUATED THE DEVICE AND FOUND DISTAL END OF OPTICAL FIBER PROTRUDING WHICH RESULTED IN A HIGHER ENERGY FLUENCE. THIS CAUSED THE LASER DEVICE TO OPERATE OUT OF SPECIFICATION BEYOND THE 20% NOMINAL ENERGY RANGE. CYNOSURE BECAME AWARE ON (B)(6) 2014, BUT BASED ON AN ADDITIONAL REVIEW/EVALUATION, THIS INCIDENT IS REPORTABLE NOW. PATIENT DID ALSO EXPERIENCE SOME MILD EDEMA ON FACE, BUT THAT IS AN EXPECTED SIDE EFFECT FROM LASER TREATMENTS.
Description of Event or Problem · 1
LASER DEVICE EMITTED AT A HIGHER FLUENCE OF ENERGY (OPERATED OUT OF SPECIFICATION), WHICH COULD LEAD TO POTENTIAL SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555819 | ELITE+ | ELITE+ | GEX | CYNOSURE INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |