Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*. The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
Recall
- Recall Number
- Z-0687-2018
- Event Number
- 78704
- Firm
- Cosman Medical, LLC
- FEI Number
- 3006630150
- Product Code
- GXI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 5, 2017
- Terminated
- September 14, 2018
- Address
- 22 Terry Ave, Burlington, MA, 01803-2516
Description
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*. The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.
The firm, Cosman Medical, sent an "Urgent Medical Device Correction" notice and Field Correction Reply Verification Tracking Form dated July 5, 2017 to their customers. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: 1. Immediately discontinue use of devices that have already been used. Used TCN Electrodes should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures. 2. Unused/un-opened TCN Electrodes should be identified as single use only (for one patient). These devices are supplied as non-sterile which require cleaning and sterilization prior to use. These TCN Electrodes may be used once the cleaning and sterilization steps are completed. After single use, the used TCN Electrode should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures. 3. Complete and return the Field Correction Reply Verification Tracking Form. via Email: [email protected] or via Fax to: 781-272-6563 - Identify your email with TCN Electrodes Action in the subject line. Customers with questions may call 1-888-8COSMAN or email [email protected].
Worldwide Distribution: US (nationwide) and country of Canada.
11250 units (10,460 USA; 790 OUS)