It was reported that before a navio tka procedure, after initially calibrating a "re-initializing camera" message was prompted when the system said the camera became disconnected.They checked cable connections and after several minutes of waiting for hardware connection to reestablish without success, they proceeded to reboot the system in addition to re-connecting the cables.After multiple attempts of these steps without successful camera connection, they resorted to swapping the camera for the backup camera the hospital had in storage.The cases proceeded without further error messages.The delay was less than 30 minutes and no patient was harmed.No other complications were reported.
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H3, h6: the ndi camera polaris spectra, part number pfsr200027, serial (b)(6) and intended to be used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.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.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 or provided at a future date, this evaluation will be reopened for investigation.
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