Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The cusaexcel 23khz straight handpiece was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint: evaluation verified customer information as valid.The transducer was found to be twisted in the handpiece housing.This was a user mistake, as the torque base was not used.The housing and all o-rings of the coil form were replaced, and the calibration and a full function test according to manufacturer specification has been performed.Root cause - the root cause has been confirmed as handpiece overtorqued due to incorrect assembly and disassembly of the handpiece by the customer using the torque wrench.This resulted in the torque wrench misaligning the dot on the handpiece and the handpiece.The ability for customers to execute the instructions as written in the current user manual and was verified by conducting a usability study.The risk remains acceptable.
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