The device used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported problem was confirmed.During the handpiece connector test, where the cable is flexed, an exposure motor control failure error occurred while bending the strain relief.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "connection problem - instrument-instrument" identified similar events.The most likely cause of this event is the electrical failure of the cable.No containment or corrective actions are recommended at this time.
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It was reported that the handpiece kept failing during the case and it was required to recalibrate each time.Checked that all attachments were on properly, and nothing disrupting the burr however the "handpiece failure" kept happening.It happened 3 times during the case.Able to proceed after reassembling and recalibrating each time, however it caused a delay of fewer than 30 minutes and no patient injuries were reported.
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