The analysis of the product did show that it has been produced and delivered in 02/1997.Since that time it was never sent in for a service/ repair/ check! the product has many small nicks spread over the whole head of the instrument.This shows that it received over the last 18 years hits from the environment.Such hits cause that the screw connection of the back cap button gets unlocked.Due to the vibration of the treatment it gets slowly unscrewed until it drops off.As there was no maintenance of the handpiece it was not recognized that the back cap was unlocked.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.This service interval depends on the frequency of use and should be adjusted accordingly.A typical service interval would be annual or bi-annual.The ifu requests also that prior to each treatment the product gets checked visually and functionally.Incident occured in (b)(6) and is reported to fda as similar products get distributed in the us.
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