MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE

Model Number F-TB

Device Problem Device Handling Problem (3265)

Patient Problems Sore Throat (2396); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The part that has been inserted into the patient's airways is the protective cover (release liner) 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 ((b)(4)) 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 2017, leonhard lang had received an almost identical complaint from another location in the (b)(6) also involving an i-gel single use supraglottic airway device.Leonhard lang has been manufacturing approximately (b)(4) ecg electrodes a year which have comparable transparent thermoformed plastic covers for individual electrodes.No other complaint of this nature has been received.We conclude that a user error has caused the incident not following the user guide of the i-gel single use supraglottic airway device.

Event Description

On june 14th, 2019, we have been informed about an incident with an ecg electrode.During a cystoscopy procedure at (b)(6), monitoring ecg electrodes model skintact f-tb and an i-gel supraglottic airway device have been used.The initial report stated: "a patient recently presented 2 days following general anaesthetic for cystoscopy with severe sore throat and dysphagia.Under a repeat general anaesthetic the plastic back of an ecg sticker was extracted from his pharynx.It seems likely that this adhered to the i-gel when it was removed and reinserted at the start of the case.We have alerted all anaesthetists at our institution to the importance of correct disposal of all waste items, and are conducting an internal investigation." the initial reporter was also providing photos showing the products involved and how the plastic back (release liner of ecg electrode, diameter 50 mm) may have adhered to the i-gel and not been seen.No further details have been disclosed so far.

Manufacturer Narrative

The part that has been inserted into the patient's airways is the protective cover (release liner) of an ecg electrode, which is removed from the device when the electrode is applied to a patient.It is then discarded.The part is transparent, 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.(b)(6)2017 , leonhard lang had received an almost identical complaint from another location in the uk also involving an i-gel single use supraglottic airway device.Leonhard lang has been manufacturing approximately 250 billion ecg electrodes a year which have comparable transparent thermoformed plastic covers for individual electrodes.No other complaint of this nature has been received.We conclude that a user error has caused the incident not following the user guide of the i-gel single use supraglottic airway device.

Event Description

On (b)(6)2019 , we have been informed about an incident with an ecg electrode.During a cystoscopy procedure at (b)(6)hospital foundation nhs trust, uk, monitoring ecg electrodes model skintact f-tb and an i-gel supraglottic airway device have been used.The intital report stated: "a patient recently presented 2 days following general anaesthetic for cystoscopy with severe sore throat and dysphagia.Under a repeat general anaesthetic the plastic back of an ecg sticker was extracted from his pharynx.It seems likely that this adhered to the i-gel when it was removed and reinserted at the start of the case.We have alerted all anaesthetists at our institution to the importance of correct disposal of all waste items, and are conducting an internal investigation." the initial reporter was also providing photos showing the products involved and how the plastic back (release liner of ecg electrode, diameter 50 mm) may have adhered to the i-gel and not been seen.On july 09th we have received additional information.The patient was a "slim, relatively fit 83 year old man (.)." after the procedure, "the patient complained of a sore throat in the recovery area, and coughed up some blood, but was reassured that sore throat is a normal side effect of anaesthesia.He was discharged home later that day, and represented [himself] the following evening with complete dysphagia since the time of surgery, and severe sore throat.On later questioning, he described an episode of complete airway obstruction at home on the evening of surgery, when he could not breathe at all after taking a mouthful of water.His wife thumped him on the back which resolved the breathing difficulty." we also received a photo showing the plastic back (release liner of ecg electrode) after it was removed from the patient's pharynx.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 8762335
• MDR Text Key: 150119580
• Report Number: 8020045-2019-00017
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000886
• UDI-Public: (01)19005531000886
• Combination Product (y/n): N
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: F-TB
• Device Lot Number: 190308-0228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 83 YR