It was reported that, during set up for navio assisted pfa procedure, the navio camera cart was not able to be detected.Two system reports were also tried but with no success.No prompts were indicated but the collar portion of the cable was not engaging well with the navio unit.The procedure was completed with manual instrumentation.The patient was not harmed.
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The navio camera cart, part number pfsr110001, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release the provided product identification information (lot) did not match any known release of this part.Refer to navio surgical system user¿s manual, section setting up and positioning the navio¿ surgical system for proper navio camera cart set up and handling.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with internal camera to poe cable or poe injector.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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