H3, h6: the ndi camera polaris spectra, pfsr200027, sn (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.The camera was connected to a navio system.The infrared lamp failure error did not present during case setup.The camera was connected to the ndi toolkit and the camera event log did not identify an infrared failure.A tracking failure alert did present.However when the camera warmed up, within 60 seconds, the gui allowed handpiece calibration to proceed.Although the reported problem was not confirmed, factors contributing to the reported symptom may have been associated with the user not giving the camera time to complete the warming process.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.
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