FDA Adverse Event
Malfunction
Summary report: N
LUMENIS ONE
MDR report key: 6113486
·
Received November 18, 2016
Report
- Report Number
- 3004135191-2016-00041
- Event Type
- Malfunction
- Date Received
- November 18, 2016
- Date of Event
- November 14, 2016
- Report Date
- November 18, 2016
- Manufacturer
- LUMENIS, LTD.
- Product Code
- GEX
- PMA / PMN Number
- K060448
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
LUMENIS INVESTIGATED THE REPORTED COMPLAINT. A LUMENIS TECHNICAL EXPERT COMPLETED AN EXAMINATION OF THE SUBJECT DEVICE IDENTIFYING A CRACK IN A COOLANT TUBE FITTING TO BE THE CAUSE OF THE EVENT REPORT. LUMENIS IS REPORTING THIS COMPLAINT SINCE IT IS SIMILAR TO AN EVENT IN WHICH THE COOLING SYSTEM LEAK RESULTED IN COMBUSTION OF THE HIGH VOLTAGE POWER SUPPLY. THE ORIGINAL MDR WAS MDR 3004135191-2012-00063-(B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT A COOLING SYSTEM LEAK OCCURRED IN A LUMENIS ONE LASER. NO REPORT OF RELATED INJURY WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764770 | LUMENIS ONE | INTENSE PULSE LIGHT DELIVERY DEVICE | GEX | LUMENIS, LTD. | LUMENIS ONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |