Health Canada — Medical Devices · Canada · 2020-12-04 · Type II
As described by Health Canada — Medical Devices: IceFORCE™, IcePearl™, IceRod™, IceSphere™, IceSeed™, IceEDGE™ Cryoablation Needles and Prostate Cryoablation Kits (2020-11-18)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Gas leaks from the needle shaft that determined some users of these devices are not adhering to the preparation technique described within the products' Instructions for Use (IFU), which ensures needle integrity of the entire needle shaft. This advisory is intended to reinforce existing instructions within the IFU directing users to fully submerge the entire needle shaft in sterile water or saline prior to the patient being anesthetized to identify a possible defective needle, therefore reducing the likelihood of patient harm from a gas shaft leak during the procedure.
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