It was reported that during a navio procedure, there was an pfs control failure during case.The handpiece was replaced and the system was rebooted, but an error occurred during initialization: pfs control hardware failure.(errcode = 400000000000).The procedure was continued with manual instruments.No other complications were reported.
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H3, h6: the navio handpiece, part number pfsr110137, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The evaluation followed a performance verification.The device performed as intended with no errors present during evaluation.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 has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is potential 4-10 error induced by a handpiece used prior to the one associated with this case.The surgical technique guide provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿ per the clinical evaluation, there was no reported patient injury/impact resulted.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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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