This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.Manufacturing device.History record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was in good condition with no appearance of any physical damage.Motor rate error was found at event history log.Motor rate error was found during occlusion test.The root cause for the report issue was found to be combination of leadscrew and clutch halves does not operate as intended.The replaced leadscrew and clutch halves also replaced worm coupling for preventive.Performed occlusion test and all functional testing which passed.
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