FDA Adverse Event
Malfunction
Summary report: N
QUANTA SYSTEM S.P.A.
MDR report key: 3972827
·
Received July 25, 2014
Report
- Report Number
- 3004378299-2014-00058
- Event Type
- Malfunction
- Date Received
- July 25, 2014
- Date of Event
- July 18, 2014
- Report Date
- July 23, 2014
- Manufacturer
- QUANTA SYSTEM, S.P.A.
- Product Code
- GEX
- PMA / PMN Number
- K091909
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROBLEM WAS DUE TO BROKEN CAVITY MIRRORS. AFTER THE REPLACEMENT OF THESE COMPONENTS, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT PATIENT INJURY.
Description of Event or Problem · 1
THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "NO LASER EMITTED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436013 | QUANTA SYSTEM S.P.A. | SURGICAL LASER | GEX | QUANTA SYSTEM, S.P.A. | LITHO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |