As part of palisades dental's investigation, on 01-jun-2018 a review of palisades dental sales records confirmed the sale of (b)(4) on 25-mar-2016 to (b)(4).In (b)(4).Records further indicate that the handpiece has not been at palisades dental for service since it was originally sold.A review of manufacturing records for (b)(4) did not find any abnormalities with the batch record or associated records.On 05-jun-2018 handpiece (b)(4) was received and evaluated.The following was found: cap and turbine are non-palisades dental parts.Palisades dental has determined that the failure of handpiece (b)(4) is not manufacturer related, rather it is related to service that did not comply to manufacturer's recommendations, and/or the use of non-palisades dental parts - any or all of these factors contributed to the alleged failure.Palisades dental has determined that either use of non-palisades dental parts and/or service that did not potentially contributed to the event.Palisades dental deems no action needed since the ifu instructs the user on returning the device to palisades dental for evaluation and service.
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