Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Gyrus ACMI, Inc. (Olympus), has issued a medical device safety alert concerning its Olympus SOLTIVE SuperPulsed Laser System [Model Number: TFL-PLS; All Serial Numbers] [HKMD No.:220135].
The manufacturer received a complaint regarding the Soltive Laser System preset laser settings. The term “Bladder Stone” was incorrectly translated in both Spanish and Portuguese to “Kidney Stone” (Cálculo renal) on the systems’ Graphical User Interface (GUI). As a result of the incorrect Spanish and Portuguese translation from “Bladder Stone” to “Kidney Stone” on the GUI, there is a potential to deliver an incorrect or unintended amount of energy to the patient’s anatomy. This issue is specific to the preset laser settings and does not affect users who are not utilizing the preset option.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Sep 2024