MAUDE Adverse Event Report:; HANDPIECE, AIR-POWERED, DENTAL

Device Problem Gas/Air Leak (2946)

Patient Problems Pulmonary Emphysema (1832); Pain (1994)

Event Type  Injury  

Event Description

This is a follow-up report for submission 1416605-2018-00009.This additional information was provided by the manufacturer on 12/21/2018.On (b)(6), the patient is feeling better, but still has some pain in the ear.The doctor said to give it a month and see if she feels better.The condition is stable.The device could not be identified; therefore the school isolated all the devices that were used for the course (21 devices) and is currently organizing the return to the manufacturer for investigation.The device is directly connected to the dental unit; thus the air pressure is set via the dental unit.The air pressure of the dental unit was not re-checked before the treatment as confirmed by the clinician that treated the patient.When checked after the treatment it was 60 psi which is beyond the safety recommendations in the manufacturer's ifu fb-543/hs rev a; which specifies that the air pressure should be between 2.7 bars and 3.5 bars (39 psi and 50 psi).This factor could have contributed to the incident, but the manufacturer needs to verify the devices and assess the hospital record of the patient to clearly establish if it caused the event or if there is another root-cause to the incident.The ifu also warns that "the supragingival air/powder jet is powerful.It can cause injury to the gums or an emphysema caused by the introduction of air into the soft tissue spaces.It is strongly recommended that the operator never direct the nozzle directly at the gum tissue or into the gingival sulcus".All the dental units were isolated until the air pressure is checked.The manufacturer asked the patient if she agrees to share her medical records to investigate this case, but this request was refused as it contains personal information.The patient agrees to share the medical records with a physician selected by the manufacturer.Additional information 12-20-2018: 22 devices were returned for evaluation to ems.Serial numbers of the devices are: (b)(4).1 of the devices ((b)(4)) has a small air leakage related to the check valve.Otherwise all the devices are within the specification according to our after sales testing procedure.The manufacturer has planned to measure the dynamique air pressure inside the powder chamber with an air pressure output set a 3.5 bars (the specification) and then at 4.1 bars (setting observed after the incident) to evaluate if there is any decrease in the performance of the device.The patient was put in contact with a medical doctor to analyse the medical records.For the time being we have no further feedback.

• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• MDR Report Key: 8236175
• MDR Text Key: 132776791
• Report Number: 3004096429-2018-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1