The navio handpiece part number 110137, sn (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device was confirmed.Nothing was identified visually that contributed to the reported problem.The reported problem was confirmed.The handpiece produced a communication error during the test when flexing the cable at the handpiece end.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is failure of the wiring connection.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
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