Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its ClosureRFG Radiofrequency Generator RFG3 [CD Part Number PT00054359; Affected Serial Number in Hong Kong: 20162138PX19, 20162902PX19, 20181911PX0B].
The notification is to provide users with important information regarding an update to the Operation Manual for the affected products. The issue does not affect the RFG3 device itself or its operation. The Operation Manual revision corrects six errors and adds clarity and/or corrects language in several sections of the manual. The RFG3 maintains compliance to all applicable medical device safety standards. There are no other model numbers of Medtronic devices affected by this revision.
According to the manufacturer, through 9 July 2019, the manufacturer has received zero complaints as a result of these revisions. The manufacturer is not retrieving product from the field as no patient safety risk has been identified. Patients who have been, or will be, treated with RFG3 should continue to be managed according to the standard patient management protocols.
Users are advised to review the Operation Manual Updated Language as provided and store a copy with the current Operation Manual.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 1 August 2019