A device history record review was performed and the device was found to have met all specifications.The sterilization records were reviewed and there were no deviations found during the process.Review of complaints does not show any similar reports related to a device failure.No further updates have been provided, if any further information is provided a follow up report will be submitted.The other reports related to the observational study are: 1219977-2014-00055, -00056, -00057, -00058, -00060, -00061, -00062, -00063, -00064, -00070, -00074, -00077, -00098.
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