Solus Flexible Wire-reinforced Laryngeal Mask Airways 의 안전성 경고

Safety alert

2017-03-30

2017-03-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170330.html

Medical device safety alert: intersurgical ltd solus flexible wire-reinforced laryngeal mask airways intersurgical ltd has issued a medical device safety alert concerning its solus flexible wire-reinforced laryngeal mask airways. the affected devices are identified as follows:- solus flexible, small adult, wire-reinforced laryngeal mask airway 3 solus flexible, medium adult, wire-reinforced laryngeal mask airway 4 ref numbers: 8003001, 8004001 lot numbers: 31610466 (ref number 8003001), 31612211 (ref number 8004001) the manufacturer has voluntarily initiated a global corrective action of specific product codes and associated lots of solus flexible wire-reinforced laryngeal mask airways. all other solus products are unaffected. a manufacturing fault in the tube supplied to intersurgical for production of the device can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient. the outcome for the patient will depend on a number of variables, including the degree of occlusion and how quickly the source of the problem is identified allowing remedial action to be taken. an internal assessment of product performance, including a review of customer complaints has confirmed these devices represent a potentially serious risk to patient safety. for this reason and to prevent any potential risk of harm, all of the affected products must not be used and must be destroyed. affected users should take the following actions:- stop the use of all affected devices. ensure that all of the affected devices in stock are quarantined. 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 30 march 2017.