It was reported that, during set up for a navio assisted ukr surgery (before the patient was under anesthesia), the navio was plugged in and turned on.A ups error message prevented them from doing the case (error message #2404000000000).The procedure was cancelled.The patient is healthy and awaiting for the surgery.
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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 was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.A handpiece test was performed on the customer device.The system outputted a handpiece communication error midway through the testing.Upon rebooting the cpu to address the error, the system outputted a "4-10" error.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 probable cause of the reported problem is electrical failure within handpiece cable.A historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions determined this case and associated lot or serial number is associated with a capa and no further action is required.The customer reported failure was addressed in a capa investigation.A revision was made to the siu hardware in response to the investigation.The failure mode and associated risk have been anticipated within the risk file and that 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 and trended through post market surveillance activities.
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