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.
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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.
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