The cori touchscreen pn rob10003, sn (b)(6), used in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.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 has identified prior events.No reasonable contributing factors could be identified based on the received complaint information and investigation results.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.Refer to the cori user manual to the recovery procedure guidelines section that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, no patient injury or impact was reported and there was no intervention necessary due to the reported event.Smith & nephew has not received adequate materials to fully evaluate the complaint, but if additional relevant materials are later received the complaint can be reopened.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.
|