Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Department of Health (DH) today (March 8) drew users’ attention to an adverse event report related to the PowerPort MRI ISP w/ 8Fr Groshong Cathether & Introducers.
Hospital Authority (HA) submitted an adverse event report of ten incidents related to full or partial breakage of PowerPort MRI ISP w/ 8Fr Groshong Cathether & Introducers. According to the available information, the device is not listed under the Medical Device Administrative Control System (MDACS).
DH immediately launched the investigation and contacted the local supplier of the concerned device. According to preliminary information from the local supplier, the affected device is distributed in Hong Kong. Investigation is on-going.
If you are in possession of the affected products and identified similar incident related to the device, please submit adverse event report to the Medical Device Adverse Event Reporting System: https://www.mdd.gov.hk/en/mdacs/report-adverse-events/index.html
Taking reference to the recommendations of the Global Harmonization Task Force, the MDACS established a Medical Device Adverse Event Reporting System to collect and conduct analysis on information related to adverse event for early detection of safety signals so as to protect the health of patients and users of medical device. An adverse event report is not a conclusion that the device(s) caused or contributed to the adverse event.
Users of medical devices, are reminded that the device should be assembled, mounted, used and maintained in accordance with the manufacturer’s advice and the device’s instruction for use (IFU).
Posted on 8 Mar 2023