GlideScope Reusable GVL and AVL Blades 의 안전성 경고

Safety alert

2013-05-27

2013-05-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130527.html

Medical device safety alert: verathon glidescope reusable gvl and avl blades medical device manufacturer, verathon, has issued a field safety notice concerning glidescope reusable gvl and avl blades. the affected blades are provided with specific “builds” of the glidescope video laryngoscope, model numbers gvl 3 0574-0007, gvl 4 0574-0001, and gvl 5 0574-0030; and agvl 2 074-0118, agvl 3 0574-0115, agvl 4 0574-0116, and agvl 5 0574-0117. these blades were manufactured between august 2011 and june 2012. this safety alert does not apply to ranger blades or single use systems, including video batons and stats. in blades built, verathon has identified a possible flaw induced along the seams of the plastic blades as a result of using a handheld plasma torch to clean the seam surfaces and camera location before bonding. during its operation to generate a plasma bond, the handheld plasma torch produced a localized intense heating of the plastic to a high temperature. that inadvertent spot heating of the plastic at the seam and the camera location induced unintended localized stress into the area surrounding the seam and camera. verathon has become aware of several patient incidents of a fracture/breakage of the laryngoscope blade resulting in a detached piece remaining in the patient airway requiring medical intervention to remove the component. the manufacturer advises customers to discontinue use of these products and to return the products to the manufacturer. if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 may 2013.