Medical device manufacturer, Terumo Cardiovascular Systems (CVS) Corporation has issued a field safety notice concerning its Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel, with the following details:
The manufacturer is recalling certain lots of Hercules 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site. The manufacturer has received nine complaints of the pins and sleeve separating from the device either prior to or during a procedure since May 2013.
There are no reported injuries as a result of this issue. The pin and sleeve components are made of stainless steel and have a relatively smooth surface with no sharp or pointed features. If a component falls into a patient's body cavity, it is unlikely to cause patient injury. The event could, however, lead to delay in procedure as the surgeon retrieves the component. Other risks involve not having a back-up device which could necessitate converting from an off-pump procedure to an on-pump procedure using a heart-lung machine. This would create a delay in procedure and eliminate the potential benefits associated with a beating heart procedure.
The manufacturer has determined that this issue is a result of a design change in the manufacturing process that occurred prior to the manufacturer acquiring the product line and the manufacturer is taking corrective action.
The manufacturer advises users to stop using Hercules 360 Universal Stabilizing Arms from the affected serial number range and return all affected product to the manufacturer. Furthermore, the manufacturer will provide users with a Hercules 3 Universal Stabilizing Arm for interim use until a replacement Hercules 360 Universal Stabilizing Arm is available (expected in October 2014).
According to the local supplier, the affected products were NOT distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 16 Sep 2014