GlideScope Reusable GVL, AVL, and Ranger Blades 의 안전성 경고

Safety alert

2013-05-27

2013-05-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130527a.html

Medical device safety alert: verathon glidescope reusable gvl, avl, and ranger blades medical device manufacturer, verathon, has issued a field safety notice concerning all serial numbers of glidescope reusable gvl, avl, and ranger blades. this safety alert applies to all models of glidescope reusable blades currently in the field: reusable gvl 2 0574-0010, gvl 3 0574-0007, gvl 4 0574-0001, and gvl 5 0574-0030; avl reusable 2 0574-0118, avl reusable 3 0574-0115, avl reusable 4 0574-0116, and avl reusable 5 0574-0117; and ranger gvl 3 0574-0029, ranger gvl 4 0574-0028, and ranger gvl 4 with 2 foot cable 0574-0018. it does not apply to single use systems, including video batons and stats. the manufacturer has become aware that glidescope video laryngoscope customers continue to use reusable laryngoscope blades even when the blades show signs of serious wear and tear. the statement instructing users to inspect and monitor the product is currently located in the middle of the user’s manual under general maintenance information. this statement may not be sufficiently prominent to ensure that users do, in fact, inspect blades for wear and tear. therefore, verathon initiated a voluntary correction to strengthen the product labeling for all glidescope reusable blade. the manufacturer is highlighting the following warning statement in the user guide: "to ensure patient safety, routinely inspect the glidescope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, or any other indication of wear. if found, do not use the damaged or worn blade, otherwise blade breakage may occur which could cause patient injury or death. always ensure that alternative airway management methods and equipment are readily available." if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 may 2013.