The part that has been inserted into the patient's airways is the protective cover of an ecg electrode, which is removed from the device when the electrode is applied to a patient.It is then discarded.The part has a diameter of 50 mm and has a thermoformed cup at its center.It appears such a cover has gotten stuck to the i-gel device prior to its insertion.The user guide of the i-gel single supraglottic airway device (http://www.Intersurgical.Com/products/airway-management/i-gel-supraglottic-airway#downloads) states: "inspect the device carefully, check the airway is patent and confirm there are no foreign bodies or a bolus of lubricant obstructing the distal opening of the airway or gastric channel." because of the size and geometry of the ecg electrode's protective cover it could not have been easily overlooked if these instructions had been properly followed.In the last 5 years, leonhard lang has manufactured more than one billion of ecg electrodes which have comparable transparent thermoformed plastic covers (covers for single electrodes) without similar complaints.We therefore assume that this incident cannot be attributed to a deficiency of the design of the product.We therefore conclude that a user error has caused the incident.Device not returned to manufacturer.
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On (b)(6) 2017, we have been informed about an incident with an ecg electrode.During an unknown procedure in (b)(6), monitoring ecg electrodes model skintact f-tb1 and an i-gel supraglottic airway device have been used.The initial report stated "ecg dot backing (a clear plastic cover which protects the adhesive and electrode and is peeled-off the back of the ecg dot before use) inadvertently inserted into a patients airway, likely to have been stuck to an i-gel supraglottic airway during preparation.The backing is made from clear plastic and is therefore difficult to see, and is small enough to be inadvertently inserted into airway.Patient complained of sore throat and sensation of foreign body post-op.Returned to theatre to have foreign body removed uneventfully.No persisting injury.This model of ecg dot has removed from theatres, and replaced with ecg dots which are packaged as a set of three, therefore having a larger plastic backing strip, which is more noticable and too large to be inserted into the airway.Other measures including local learning." no further details have been disclosed so far.
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