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, Megadyne Medical Products, Inc., has issued a medical device safety alert concerning MEGADYNE Suction Coagulators [Product Code: 004125, 004225, 004325; UDI/GTIN: 10614559105146, 10614559105153, 10614559105160; Exp Date: June 30, 2023 - October 31, 2027] [HKMD No.: 190236].
The manufacturer identified a potential issue during internal testing on the Suction Coagulator product family which may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit. According to the manufacturer, when the issue presents as self-activation, inadvertent thermal injury may occur. Thermal damage to unintended organs/tissues/vessels may require significant surgical intervention to prevent permanent impairment of patient body structure/ function. In addition to potential impact to patients, fluid ingress may result in the device operator experiencing mild shock. Based on the voltage and current involved in this situation, potential harm includes tingling feelings and small burns.
The manufacturer advised affected users to identify, quarantine and return the affected products.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Jun 2023