Device product
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
Z-1695-2020
Product summary
- Event
- Event 85085
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-1695-2020
Official wording
Reason: The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Code information: TCN-10-3M; GTIN: 00813250017502; Lot Numbers: 23049683, 23239528, and 23239529.
Distribution pattern: US Nationwide distribution in the states of AZ, CA,CO, FL,GA, ID,IL, IN, KY, MA, MD, MI, MO, NV, NY, OH, OK, OR, SC, TX, UT, VA, WA, and WI.
Derived failure modes
-
Unknown
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.