Device product
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
Z-1325-2019
Product summary
- Event
- Event 82274
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157 devices
- Official record key
device-enforcement:Z-1325-2019
Official wording
Reason: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Code information: Lot/Serial numbers: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.
Distribution pattern: Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
Derived failure modes
-
Unknown
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.