FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 002-1100 15W THERMAL THERAPY
MDR report key: 5442450
·
Received February 17, 2016
Report
- Report Number
- 1723170-2016-00213
- Event Type
- Malfunction
- Date Received
- February 17, 2016
- Date of Event
- January 20, 2016
- Report Date
- April 19, 2016
- Manufacturer
- MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
- Product Code
- GEX
- PMA / PMN Number
- K081656
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DUE TO THE AGE OF THIS SYSTEM, NO TESTING WAS PERFORMED AND THE SYSTEM WAS RETIRED FROM SERVICE.
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE'S LASER THERMAL ABLATION THERAPY SYSTEM'S LASER SHOWED A LASER ERROR WHEN WE TRIED TO FIRE IT. THEY USED THREE DIFFERENT LASER DIFFUSING FIBERS (LDF), HOWEVER, THE LASER DID NOT EMIT ANY POWER OR THE EXPECTED AUDIBLE RING. ISSUE WAS DISCOVERED AT PRM DURING SYSTEM DEMONSTRATION. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98975 | SYSTEM 002-1100 15W THERMAL THERAPY | POWERED LASER SURGICAL INSTRUMENT | GEX | MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |