FDA Adverse Event
Malfunction
Summary report: N
SPECTRANETICS EXCIMER LASER SYSTEM
MDR report key: 3251109
·
Received July 29, 2013
Report
- Report Number
- 1721279-2013-00110
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- June 28, 2013
- Report Date
- June 28, 2013
- Manufacturer
- SPECTRANETICS CORPORTATION
- Product Code
- MFA
- PMA / PMN Number
- P910001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CUSTOMER DAMAGED THE POWER CORD AND TRIED TO USE THE LASER WHEN THE POWER CORD GAVE A SPARK. THEY COULD NOT USE THE LASER FOR THE CASE. NO AE OCCURRED. IT WAS DETERMINED THAT THE POWER CORD HAD BEEN DAMAGED BUT HAD NOT FALLEN OUT OF THE BACK OF THE LASER SYSTEM. FIELD SERVICE WAS DISPATCHED, THE POWER CORD AND ANCHOR WERE REPAIRED AND THE CUSTOMER WAS INSTRUCTED ON THE PROPER PROTOCOL FOR POWER CORD REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352364 | SPECTRANETICS EXCIMER LASER SYSTEM | CVX-300 EXCIMER LASER | MFA | SPECTRANETICS CORPORTATION | CVX-300 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |