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, Intuitive Surgical Inc, has issued a medical device safety alert concerning ASSY, USM, IS4000 da Vinci Xi Surgical System and da Vinci X Surgical Systems [Part Number: 380647; Unique Device Identifier: 00886874114216] [HKMD No.: 220174].
The manufacturer is informing users that a population of the da Vinci X and Xi system instrument arms (USMs) have Instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel like it is not tightly connected to the rail. This condition may also lead to increased friction along the insertion axis.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 Mar 2023