MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. DENTAL ABRASIVE AIR JET SYSTE HANDPIECE; AIR FLOW HANDY 2

Model Number FT-170

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2014

Event Type  malfunction  

Event Description

The dentist was busy performing a treatment to a pt, when he put the device under pressure, few drops of water come out without air and dust.Immediately after the device set off by itself and because of the internal pressure, the handpiece was projected to the floor.

Manufacturer Narrative

This incident reported could have occurred when the handpiece nozzle is clogged, thus, in our ifu (b)(4), we give recommendation to avoid any clogging on the handpiece (p36) and we warned the customers on this issue in the trouble shooting section.After investigation of the af handy 2+ device, we noticed that the handpiece could be connected and disconnected too easily.The handpiece is worn, it presented some marks of wear and tear.Our product quality compliance dept succeed to reproduce the defect reported internally only by putting the device under maximum pressure (4.5 bars) with clogged nozzle of the handpiece.In normal conditions (non clogged handpiece and normal pressure, the handpiece stayed in our place.As we consider that the event can occur only if the handpiece is clogged and not so well maintained by practicer.No action plan despite recommendation to dentist about maintenance has been done.The incident reported was caused by a lack of maintenance of the handpiece.

• Brand Name: DENTAL ABRASIVE AIR JET SYSTE HANDPIECE
• Type of Device: AIR FLOW HANDY 2
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer Contact: virginie siloret ; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260 ; 1229944700
• MDR Report Key: 4024258
• MDR Text Key: 19797501
• Report Number: 3004096429-2014-00005
• 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
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FT-170
• Device Catalogue Number: FT-170#A/008
• Device Lot Number: OF-12-01293-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1