FDA Adverse Event
Malfunction
Summary report: N
LUMENIS ONE
MDR report key: 3723780
·
Received April 3, 2014
Report
- Report Number
- 3004135191-2014-00020
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 14, 2014
- Report Date
- April 2, 2014
- Manufacturer
- LUMENIS, LTD.
- Product Code
- GEX
- PMA / PMN Number
- K060448
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
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.
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 |
|---|---|---|---|---|---|---|---|
| 202845 | LUMENIS ONE | INTENSE PULSE LIGHT DELIVERY DEVICE | GEX | LUMENIS, LTD. | LUMENIS ONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |