(b)(4).Batch # r94t9x.Investigation summary: the handpiece was received with the nose cone cracked.In addition, coating material of the housing was flaking off.Based on prior investigations, the loose particles on the surface are likely aluminum oxide from the base material.It was connected to a generator, evaluated with a test instrument and was found to be functional.The instrument was disassembled to inspect the internal components and the moisture indicator was positive.Due to the cracked nose cone, moisture entered the hand piece mid housing.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nosecone.It is possible that the ingress of moisture affected handpiece functionality.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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