Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its TLC Retractor Self-Retaining Retractor System.
Medical device manufacturer, Stryker Endoscopy, has issued a medical device safety alert concerning its PneumoSure High Flow Insufflator. [Part numbers: 620-040-600, 620-040-601, 620-040-602, 620-040-604, 620-040-610, 620-040-611, 620-040-613, 620-040-614; Serial numbers: 1510CE0342 through 1601CE0581].
According to the manufacturer, when the device is operated in high flow mode (40L/min, 15 mmHg) and connected to a house gas inlet source, the flow rate would drop to 0L/min and the red "Check Gas Supply" symbol would appear on the display within seconds of insufflating, immediately suspending insufflation.
The failure produced by the defective product is the red "Check Gas Supply" error on the display that occurs when the insufflator has a flow setting of 18L/min or greater. During a procedure, this would result in pressure decrease in the abdomen. Unclear image due to poor abdominal distention is the hazardous situation associated with low gas pressure during a procedure.
The manufacturer advises users to return the affected products to them for re-work.
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 5 April 2016