Solus™ flexible laryngeal mask patency fault

Flexible laryngeal mask airways are frequently used for shared airway procedures. The wire reinforcement allows flexion without kinking or cessation of gas flow. We would like to report two separate incidents of apparent manufacturing faults of the Solus™ flexible wire reinforced laryngeal mask airway (Intersurgical, Wokingham, UK). In both cases, the patency of the airway was seriously compromised by silicone material narrowing the internal diameter of the device; this was not immediately apparent on visual inspection. Both airways were used in clinical practice. In one case, this fault almost completely occluded the airway device mid-way along its length. The fault was identified on closer inspection following high airway pressures and difficulty in ventilating during use (Figs. 1 and 2). In the second case, the occlusion was less severe and was identified following a period of high airway pressures (Fig. 3). The faulty airways were from different batches. All devices of the same batch numbers were withdrawn from use immediately and reported to Intersurgical, and the Medicines and Healthcare products Regulatory Agency (MHRA). The relevant AAGBI Safety Guidelines 1 state that all airway equipment including laryngeal mask airways should ‘have been checked for patency’ before use but, unlike for heat and moisture exchange (HME) filters and catheter mounts, do not recommend ‘ensuring gas flow through the whole assembly when connected to the breathing system’. Given that this patency compromise is not immediately obvious on visual inspection, we recommend extra vigilance.