(b)(4).Batch #: r9434l.Investigation summary: the device was received with no apparent damage.The handpiece was assembled and disassembled to a test instrument without any difficulty.Then, the handpiece was connected to a gen11 and was found to be functional.The instrument was disassembled to inspect the internal components.The moisture indicator was positive.The handpiece has a number of seals to prevent fluids from entering the housing."positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal, this may be caused by a reduction of the compressive force on the distal seal.However no definitive root cause could be drawn.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It is probable that the ingress of moisture affected handpiece functionality.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
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