MAUDE Adverse Event Report: E.M.S ELECTRO MEDICAL SYSTEMS S.A. DENTAL ABRASIVE AIR JET SYSTEM; AIR-FLOW MASTER PIEZON

Model Number FT-200

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

The customer reported us that the en-060/a handpieces (more specifically the tip) used with its air flow master piezon device number (b)(4) have burnt several (2 or 3 pts during treatment.

Manufacturer Narrative

According to the info reported by our distributor on (b)(4), we supposed that the issue could be related to a wrong use, however, we need to investigate deeper to confirm this hypothesis.

• Brand Name: DENTAL ABRASIVE AIR JET SYSTEM
• Type of Device: AIR-FLOW MASTER PIEZON
• Manufacturer (Section D): E.M.S ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer Contact: siloret virginie ; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260 ; 29944700
• MDR Report Key: 3696992
• MDR Text Key: 4295838
• Report Number: 3004096429-2014-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FT-200
• Device Catalogue Number: FT-200#A/001
• Device Lot Number: OF-01-10552-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other