Health Canada — Medical Devices · Canada · 2024-10-18 · Type II
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Reported risk: Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation determined that exposing the Uropass product to ultraviolet ("UV") radiation can cause brittleness of the device dilator tip, which may lead to breakage. Since April 2023, Olympus has received 2 adverse event complaints reporting broken Uropass dilator tips for devices still within their shelf life. Recall start date: October 4, 2024
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