Device product
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
Z-2692-2020
Product summary
- Event
- Event 85904
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2415 pk
- Official record key
device-enforcement:Z-2692-2020
Official wording
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Code information: Lot # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Derived failure modes
-
Unknown
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.