FDA Adverse Event
Malfunction
Summary report: N
QUANTA SYSTEM S.P.A.
MDR report key: 5130895
·
Received October 2, 2015
Report
- Report Number
- 3004378299-2015-00081
- Event Type
- Malfunction
- Date Received
- October 2, 2015
- Date of Event
- August 21, 2015
- Report Date
- September 29, 2015
- Manufacturer
- QUANTA SYSTEM, S.P.A.
- Product Code
- GEX
- PMA / PMN Number
- K091909
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROBLEM WAS DUE TO A COMPONENT FAILURE (POWER SUPPLY). AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK CORRECTLY. WE ARE UNAWARE ABOUT PT INJURY.
Description of Event or Problem · 1
THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "THE LASER DISPLAYED A LOW POWER ERROR DURING USE". NO ADVERSE EFFECTS TO PT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655709 | QUANTA SYSTEM S.P.A. | SURGICAL LASER | GEX | QUANTA SYSTEM, S.P.A. | LITHO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |