MAUDE Adverse Event Report: INTERSURGICAL UAB I-GEL; AIRWAY, OROPHARYNGEAL

Model Number 8204000

Device Problem Peeled/Delaminated (1454)

Patient Problems Dysphagia/ Odynophagia (1815); Foreign Body In Patient (2687)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not returned.A device history record review could not be conducted since the lot number was not provided.Per the anesthesiologist the i-gel went in normally and the procedure was successfully completed.It was noted in the reporting that the device was positioned on the patient's chest and lubricated on the back side of the device.Per the ifu the cuff should be lubricated on the back, sides and front of the cuff.The cuff should always be placed back into the cradle during preparation and prior to use.Per the warnings do not place onto the chest or pillow of patient, always use protective cradle/cage pack provided.It is undetermined how the introduction of the "ekg backing" was to the patient.Per the ifu pre-use check it is essential to inspect the device for damage, foreign bodies or bolus of lubricant.This includes inside the bowl to ensure the surface are smooth and intact.

Event Description

The patient reported symptoms of gagging and difficulty swallowing.This occurred 3-4 hours after procedure.The patient reached into his throat and pulled out a piece of plastic.It was transparent with blue lines and determined to be an ekg backing.

• Brand Name: I-GEL
• Type of Device: AIRWAY, OROPHARYNGEAL
• Manufacturer (Section D): INTERSURGICAL UAB; arnioniu 60/28-1; pabrade, ; LH
• Manufacturer Contact: ivan seniut ; arnioniu 60/28-1; pabrade, vilniaus apskritis, lt-4710 ; LH
• MDR Report Key: 9284664
• MDR Text Key: 166982058
• Report Number: 1319447-2019-00001
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8204000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR