H10: the device was intended for use in treatment and it was reported that navio was rolled over the cable.The device was not made available for investigation.Thus, visual and functional investigation could not be performed.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The surgical system user's manual released at the time of the complaint (pn 500097 rev e) provides instructions for checking the proper function and connection of cables.This is an identified failure mode within the risk assessment.We could confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.However, based on the information that the navio was rolled over the cable, the malfunction was due to user error.No containment or corrective actions are recommended at this time.Per complaint details, "someone rolled the navio on the cable" which required the case to be cancelled and does not represent a device malfunction.Based on the information provided, there was no patient involvement or injury; therefore, no further medical assessment is warranted at this time.Additional information on a1.
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