Device product
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Z-2391-2016
Product summary
- Event
- Event 74553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51 kits
- Official record key
device-enforcement:Z-2391-2016
Official wording
Reason: Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Code information: Lot Number M5264D205
Distribution pattern: Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Derived failure modes
-
Unknown
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),