It was reported that, during a navio procedure, the led light above the battery icon was orange even after having plugged the navio into the wall for 24 hours.The procedure was successfully completed as intended and without delay.No patient injury or other complications were reported.
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H3, h6: the navio surgical system be/fr/de, product npfs02020, (b)(6) used for treatment was not made available to the designated complaint unit for evaluation thus, visual inspection and functional testing could not be performed.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 concluded this was an isolated event.A relationship between the reported event and the device could not be established as the product was not returned.Although the reported problem was not confirmed, a contributing factor may be ups battery failure.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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