It was reported that, during set up for a navio assisted surgery, when trying to power on the navio surgical system, they kept receiving an error code of ups back up error code not working properly.Rep tried leaving it on plugged in charged but still wouldn¿t start.Everything was plugged in.Rep then tried bypassing the ups and plugging it in the wall but still didn¿t work.The procedure was completed with manual instrumentations without delays.The patient was not harmed.
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H3, h6: the navio surgical system ups,(b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The ups was plugged into ac power and will not power on.The ups has experienced a catastrophic failure.It is an oem device and further evaluation is not possible.The most likely cause of this event is an internal electronic failure of the ups rendering it completely nonfunctional.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 found one similar event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The navio surgical technique guide for knee arthroplasty provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that during set up for a navio assisted surgery, when trying to power on the navio surgical system, they kept receiving an error code of ups back up error code not working properly.The procedure was completed with manual instrumentation without delays.The patient was not harmed.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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